Vitamin D/Calcium Polyp Prevention Study

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ClinicalTrials.gov Identifier: NCT00153816

Recruitment Status : Completed

First Posted : September 12, 2005

Results First Posted : October 20, 2015

Last Update Posted : March 15, 2017

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Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Dartmouth-Hitchcock Medical Center

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Conditions	Colorectal Cancer Polyps Adenomas
Interventions	Drug: Calcium Carbonate Drug: Vitamin D3 Drug: placebo
Enrollment	2813

Participant Flow

Recruitment Details	Subjects were enrolled between July 2004 and July 2008 at 11 academic medical centers and associated gastroenterology practices in the U.S.
Pre-assignment Details	19,083 subjects were screened and 2,813 were enrolled into a run-in period of 56-84 days. 554 subjects were not randomized: 174 were ineligible due to out of range baseline lab values, 66 were ineligible for other reasons, 211 had <80% tablet adherence, and 103 refused to participate.


Arm/Group Title	Full Factorial Placebo	Full Factorial Calcium	Full Factorial Vitamin D	Full Factorial Calcium Plus Vitamin D	Two Arm Placebo	Two Arm Vitamin D
Arm/Group Description	subjects in 2X2 factorial design; r...	subjects in 2X2 factorial design; r...	Subjects in 2X2 factorial design; r...	Subjects in 2X2 factorial design; r...	Women choosing to take daily 1200 m...	Women choosing to take daily 1200 m...
Arm/Group Description	subjects in 2X2 factorial design; randomized to daily placebo placebo: placebo; two tablets per day	subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet	Subjects in 2X2 factorial design; randomized to daily 1000 IU vitamin D3 Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet	Subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate and 1000 IU vitamin D3 Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet	Women choosing to take daily 1200 mg as calcium carbonate randomized to daily placebo Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet	Women choosing to take daily 1200 mg as calcium carbonate randomized to daily 1000 IU vitamin D3 Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet
Period Title: Overall Study
Started	415	419	420	421	295	289
Completed	383	387	388	390	278	262
Not Completed	32	32	32	31	17	27
Reason Not Completed
Death	6	5	4	6	0	2
Lost to Follow-up	7	8	5	8	7	9
Withdrawal by Subject	9	9	9	4	1	5
Follow-up exam not done	8	7	11	10	8	9
Follow-up exam done, histology missing	2	3	3	3	1	2

Baseline Characteristics

Arm/Group Title		Full Factorial Placebo	Full Factorial Calcium	Full Factorial Vitamin D	Full Factorial Calcium Plus Vitamin D	Two Arm Placebo	Two Arm Vitamin D	Total
Arm/Group Description		subjects in 2X2 factorial design; r...	subjects in 2X2 factorial design; r...	Subjects in 2X2 factorial design; r...	Subjects in 2X2 factorial design; r...	Women choosing to take daily 1200 m...	Women choosing to take daily 1200 m...	Total of all reporting groups
Arm/Group Description		subjects in 2X2 factorial design; randomized to daily placebo placebo: placebo; two tablets per day	subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet	Subjects in 2X2 factorial design; randomized to daily 1000 IU vitamin D3 Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet	Subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate and 1000 IU vitamin D3 Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet	Women choosing to take daily 1200 mg as calcium carbonate randomized to daily placebo Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet	Women choosing to take daily 1200 mg as calcium carbonate randomized to daily 1000 IU vitamin D3 Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet	Total of all reporting groups
Overall Number of Baseline Participants		415	419	420	421	295	289	2259
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	415 participants	419 participants	420 participants	421 participants	295 participants	289 participants	2259 participants
		58.2 (7.0)	58.7 (7.0)	58.3 (7.0)	58.7 (6.9)	56.7 (6.0)	57.0 (6.6)	58.1 (6.8)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	415 participants	419 participants	420 participants	421 participants	295 participants	289 participants	2259 participants
	Female	60 14.5%	63 15.0%	62 14.8%	67 15.9%	295 100.0%	289 100.0%	836 37.0%
	Male	355 85.5%	356 85.0%	358 85.2%	354 84.1%	0 0.0%	0 0.0%	1423 63.0%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	415 participants	419 participants	420 participants	421 participants	295 participants	289 participants	2259 participants
	Hispanic or Latino	19 4.6%	23 5.5%	24 5.7%	26 6.2%	28 9.5%	26 9.0%	146 6.5%
	Not Hispanic or Latino	395 95.2%	395 94.3%	396 94.3%	394 93.6%	267 90.5%	263 91.0%	2110 93.4%
	Unknown or Not Reported	1 0.2%	1 0.2%	0 0.0%	1 0.2%	0 0.0%	0 0.0%	3 0.1%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	415 participants	419 participants	420 participants	421 participants	295 participants	289 participants	2259 participants
	American Indian or Alaska Native	4 1.0%	3 0.7%	2 0.5%	2 0.5%	1 0.3%	1 0.3%	13 0.6%
	Asian	8 1.9%	10 2.4%	12 2.9%	6 1.4%	8 2.7%	7 2.4%	51 2.3%
	Native Hawaiian or Other Pacific Islander	2 0.5%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	2 0.1%
	Black or African American	27 6.5%	33 7.9%	25 6.0%	46 10.9%	28 9.5%	25 8.7%	184 8.1%
	White	357 86.0%	354 84.5%	364 86.7%	350 83.1%	238 80.7%	237 82.0%	1900 84.1%
	More than one race	4 1.0%	4 1.0%	1 0.2%	0 0.0%	0 0.0%	1 0.3%	10 0.4%
	Unknown or Not Reported	13 3.1%	15 3.6%	16 3.8%	17 4.0%	20 6.8%	18 6.2%	99 4.4%
Region of Enrollment Measure Type: Number Unit of measure: Participants	Number Analyzed	415 participants	419 participants	420 participants	421 participants	295 participants	289 participants	2259 participants
Puerto Rico		7	7	7	7	5	4	37
United States		408	412	413	414	290	285	2222

Outcome Measures

1.Primary Outcome


Title	Colorectal Adenomas
Description	[Not Specified]
Description	[Not Specified]
Time Frame	1 to 10 years

Outcome Measure Data

Analysis Population Description

Subjects are included if they had a follow-up exam at least one year after randomization and had sufficient histology available to ascertain the endpoint.


Arm/Group Title	Full Factorial Placebo	Full Factorial Calcium	Full Factorial Vitamin D	Full Factorial Calcium Plus Vitamin D	Two Arm Placebo	Two Arm Vitamin D
Arm/Group Description:	subjects in 2X2 factorial design; r...	subjects in 2X2 factorial design; r...	Subjects in 2X2 factorial design; r...	Subjects in 2X2 factorial design; r...	Women choosing to take daily 1200 m...	Women choosing to take daily 1200 m...
Arm/Group Description:	subjects in 2X2 factorial design; randomized to daily placebo placebo: placebo; two tablets per day	subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet	Subjects in 2X2 factorial design; randomized to daily 1000 IU vitamin D3 Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet	Subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate and 1000 IU vitamin D3 Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet	Women choosing to take daily 1200 mg as calcium carbonate randomized to daily placebo Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet	Women choosing to take daily 1200 mg as calcium carbonate randomized to daily 1000 IU vitamin D3 Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet
Overall Number of Participants Analyzed	380	381	381	381	274	262
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of subjects
	48.2 (43.0 to 53.3)	44.9 (39.8 to 50.0)	47.0 (41.9 to 52.1)	45.7 (40.6 to 50.8)	32.1 (26.6 to 38.0)	32.4 (26.8 to 38.5)

2.Secondary Outcome


Title	Advanced Colorectal Lesions
Description	Includes: adenomas >=1 cm, adenomas with high grade dysplasia, aden...
Description	Includes: adenomas >=1 cm, adenomas with high grade dysplasia, adenomas with villous features, or cancer.
Time Frame	1 to 10 years

Outcome Measure Data

Analysis Population Description

Subjects are included if they had a follow-up exam at least one year after randomization and sufficient histology available to ascertain the endpoint.


Arm/Group Title	Full Factorial Placebo	Full Factorial Calcium	Full Factorial Vitamin D	Full Factorial Calcium Plus Vitamin D	Two Arm Placebo	Two Arm Vitamin D
Arm/Group Description:	subjects in 2X2 factorial design; r...	subjects in 2X2 factorial design; r...	Subjects in 2X2 factorial design; r...	Subjects in 2X2 factorial design; r...	Women choosing to take daily 1200 m...	Women choosing to take daily 1200 m...
Arm/Group Description:	subjects in 2X2 factorial design; randomized to daily placebo placebo: placebo; two tablets per day	subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet	Subjects in 2X2 factorial design; randomized to daily 1000 IU vitamin D3 Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet	Subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate and 1000 IU vitamin D3 Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet	Women choosing to take daily 1200 mg as calcium carbonate randomized to daily placebo Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet	Women choosing to take daily 1200 mg as calcium carbonate randomized to daily 1000 IU vitamin D3 Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet
Overall Number of Participants Analyzed	380	386	384	387	276	261
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of subjects
	9.2 (6.5 to 12.6)	11.4 (8.4 to 15.0)	10.9 (8.0 to 14.5)	9.6 (6.8 to 12.9)	6.9 (4.2 to 10.5)	7.3 (4.4 to 11.1)

Adverse Events

Time Frame	Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Adverse Event Reporting Description	Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.

Arm/Group Title	Full Factorial Placebo	Full Factorial Calcium	Full Factorial Vitamin D	Full Factorial Calcium Plus Vitamin D	Two Arm Placebo	Two Arm Vitamin D
Arm/Group Description	subjects in 2X2 factorial design; r...	subjects in 2X2 factorial design; r...	Subjects in 2X2 factorial design; r...	Subjects in 2X2 factorial design; r...	Women choosing to take daily 1200 m...	Women choosing to take daily 1200 m...
Arm/Group Description	subjects in 2X2 factorial design; randomized to daily placebo placebo: placebo; two tablets per day	subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet	Subjects in 2X2 factorial design; randomized to daily 1000 IU vitamin D3 Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet	Subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate and 1000 IU vitamin D3 Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet	Women choosing to take daily 1200 mg as calcium carbonate randomized to daily placebo Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet	Women choosing to take daily 1200 mg as calcium carbonate randomized to daily 1000 IU vitamin D3 Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet
All-Cause Mortality
	Full Factorial Placebo	Full Factorial Calcium	Full Factorial Vitamin D	Full Factorial Calcium Plus Vitamin D	Two Arm Placebo	Two Arm Vitamin D
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--	--/--	--/--	--/--
Serious Adverse Events Serious Adverse Events
	Full Factorial Placebo	Full Factorial Calcium	Full Factorial Vitamin D	Full Factorial Calcium Plus Vitamin D	Two Arm Placebo	Two Arm Vitamin D
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	84/415 (20.24%)	94/419 (22.43%)	97/420 (23.10%)	80/421 (19.00%)	64/295 (21.69%)	63/289 (21.80%)
Blood and lymphatic system disorders
Anemia ^†	2/415 (0.48%)	0/419 (0.00%)	0/420 (0.00%)	1/421 (0.24%)	1/295 (0.34%)	0/289 (0.00%)
Myelodysplastic syndrome ^†	0/415 (0.00%)	1/419 (0.24%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Cardiac disorders
Cardiac arrhythmia ^†	4/415 (0.96%)	3/419 (0.72%)	4/420 (0.95%)	3/421 (0.71%)	1/295 (0.34%)	3/289 (1.04%)
Cardiac ischemia/myocardial infarction ^†	4/415 (0.96%)	0/419 (0.00%)	6/420 (1.43%)	2/421 (0.48%)	3/295 (1.02%)	1/289 (0.35%)
Congestive heart failure ^†	3/415 (0.72%)	1/419 (0.24%)	0/420 (0.00%)	1/421 (0.24%)	0/295 (0.00%)	1/289 (0.35%)
Pericarditis ^†	0/415 (0.00%)	1/419 (0.24%)	1/420 (0.24%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Valvular heart disease ^†	0/415 (0.00%)	2/419 (0.48%)	1/420 (0.24%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Ear and labyrinth disorders
Cochlear implant ^†	0/415 (0.00%)	0/419 (0.00%)	0/420 (0.00%)	1/421 (0.24%)	0/295 (0.00%)	0/289 (0.00%)
Endocrine disorders
Thyroid disorder ^†	0/415 (0.00%)	0/419 (0.00%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Thyroid hyperplasia ^†	0/415 (0.00%)	0/419 (0.00%)	1/420 (0.24%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Gastrointestinal disorders
Abdominal pain ^†	0/415 (0.00%)	0/419 (0.00%)	1/420 (0.24%)	0/421 (0.00%)	1/295 (0.34%)	0/289 (0.00%)
Appendicitis ^†	0/415 (0.00%)	3/419 (0.72%)	1/420 (0.24%)	2/421 (0.48%)	1/295 (0.34%)	1/289 (0.35%)
Colostomy take-down ^†	0/415 (0.00%)	1/419 (0.24%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Constipation ^†	0/415 (0.00%)	0/419 (0.00%)	0/420 (0.00%)	1/421 (0.24%)	0/295 (0.00%)	0/289 (0.00%)
Diarrhea ^†	0/415 (0.00%)	0/419 (0.00%)	0/420 (0.00%)	1/421 (0.24%)	0/295 (0.00%)	0/289 (0.00%)
Diverticulitis ^†	2/415 (0.48%)	2/419 (0.48%)	1/420 (0.24%)	1/421 (0.24%)	2/295 (0.68%)	1/289 (0.35%)
Dysphagia ^†	0/415 (0.00%)	0/419 (0.00%)	0/420 (0.00%)	1/421 (0.24%)	0/295 (0.00%)	0/289 (0.00%)
Esophagitis ^†	1/415 (0.24%)	0/419 (0.00%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Gastroenteritis ^†	1/415 (0.24%)	0/419 (0.00%)	2/420 (0.48%)	2/421 (0.48%)	1/295 (0.34%)	0/289 (0.00%)
Gastroesophageal reflux disease ^†	0/415 (0.00%)	0/419 (0.00%)	1/420 (0.24%)	2/421 (0.48%)	0/295 (0.00%)	1/289 (0.35%)
Gastrointestinal hemorrhage ^†	2/415 (0.48%)	1/419 (0.24%)	0/420 (0.00%)	2/421 (0.48%)	1/295 (0.34%)	0/289 (0.00%)
Hiatal hernia ^†	1/415 (0.24%)	0/419 (0.00%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Ischemic colitis ^†	1/415 (0.24%)	0/419 (0.00%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Gastrointestinal obstruction ^†	1/415 (0.24%)	2/419 (0.48%)	2/420 (0.48%)	1/421 (0.24%)	1/295 (0.34%)	0/289 (0.00%)
Pancreatitis ^†	1/415 (0.24%)	2/419 (0.48%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	1/289 (0.35%)
Ulcer ^†	0/415 (0.00%)	1/419 (0.24%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	1/289 (0.35%)
Volvulus ^†	0/415 (0.00%)	0/419 (0.00%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	1/289 (0.35%)
General disorders
Alcohol intoxication ^†	0/415 (0.00%)	0/419 (0.00%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	1/289 (0.35%)
Altered mental status ^†	0/415 (0.00%)	0/419 (0.00%)	0/420 (0.00%)	1/421 (0.24%)	0/295 (0.00%)	0/289 (0.00%)
Altitude sickness ^†	0/415 (0.00%)	1/419 (0.24%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Chest pain ^†	7/415 (1.69%)	8/419 (1.91%)	8/420 (1.90%)	7/421 (1.66%)	6/295 (2.03%)	4/289 (1.38%)
Deviated septum ^†	1/415 (0.24%)	0/419 (0.00%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Epistaxis ^†	0/415 (0.00%)	0/419 (0.00%)	1/420 (0.24%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Febrile Illness ^†	0/415 (0.00%)	0/419 (0.00%)	0/420 (0.00%)	1/421 (0.24%)	0/295 (0.00%)	0/289 (0.00%)
Groin hematoma ^†	0/415 (0.00%)	0/419 (0.00%)	1/420 (0.24%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Multiple illnesses ^†	0/415 (0.00%)	0/419 (0.00%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	1/289 (0.35%)
Septic shock ^†	0/415 (0.00%)	0/419 (0.00%)	0/420 (0.00%)	1/421 (0.24%)	0/295 (0.00%)	0/289 (0.00%)
Sleep apnea ^†	0/415 (0.00%)	1/419 (0.24%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Syncope/near syncope ^†	2/415 (0.48%)	2/419 (0.48%)	1/420 (0.24%)	1/421 (0.24%)	1/295 (0.34%)	2/289 (0.69%)
Toxic shock syndrome ^†	1/415 (0.24%)	0/419 (0.00%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Traumatic injury ^†	0/415 (0.00%)	0/419 (0.00%)	1/420 (0.24%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
^†	0/415 (0.00%)	0/419 (0.00%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Hepatobiliary disorders
Ascites ^†	0/415 (0.00%)	0/419 (0.00%)	1/420 (0.24%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Cholecystitis ^†	0/415 (0.00%)	3/419 (0.72%)	4/420 (0.95%)	1/421 (0.24%)	1/295 (0.34%)	2/289 (0.69%)
Hepatitis ^†	1/415 (0.24%)	0/419 (0.00%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Immune system disorders
Allergic reaction ^†	2/415 (0.48%)	0/419 (0.00%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Infections and infestations
Abscess ^†	0/415 (0.00%)	1/419 (0.24%)	1/420 (0.24%)	1/421 (0.24%)	2/295 (0.68%)	0/289 (0.00%)
Bacteremia ^†	0/415 (0.00%)	0/419 (0.00%)	0/420 (0.00%)	1/421 (0.24%)	0/295 (0.00%)	0/289 (0.00%)
Bronchitis ^†	1/415 (0.24%)	0/419 (0.00%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	1/289 (0.35%)
Cellulitis ^†	2/415 (0.48%)	1/419 (0.24%)	0/420 (0.00%)	1/421 (0.24%)	1/295 (0.34%)	0/289 (0.00%)
Death ^†	1/415 (0.24%)	0/419 (0.00%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Febrile Illness ^†	0/415 (0.00%)	0/419 (0.00%)	1/420 (0.24%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Glottitis ^†	0/415 (0.00%)	0/419 (0.00%)	0/420 (0.00%)	1/421 (0.24%)	0/295 (0.00%)	0/289 (0.00%)
Infected prosthesis ^†	0/415 (0.00%)	0/419 (0.00%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	1/289 (0.35%)
Osteomyelitis ^†	0/415 (0.00%)	0/419 (0.00%)	1/420 (0.24%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Pneumonia ^†	1/415 (0.24%)	2/419 (0.48%)	1/420 (0.24%)	2/421 (0.48%)	0/295 (0.00%)	2/289 (0.69%)
Respiratory failure ^†	0/415 (0.00%)	1/419 (0.24%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Sepsis ^†	0/415 (0.00%)	0/419 (0.00%)	0/420 (0.00%)	0/421 (0.00%)	1/295 (0.34%)	0/289 (0.00%)
Upper respiratory infection ^†	1/415 (0.24%)	0/419 (0.00%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Urinary tract infection ^†	1/415 (0.24%)	0/419 (0.00%)	1/420 (0.24%)	0/421 (0.00%)	0/295 (0.00%)	1/289 (0.35%)
Wound infection ^†	0/415 (0.00%)	0/419 (0.00%)	0/420 (0.00%)	1/421 (0.24%)	0/295 (0.00%)	0/289 (0.00%)
Injury, poisoning and procedural complications
Postoperative hematoma ^†	0/415 (0.00%)	0/419 (0.00%)	1/420 (0.24%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Sigmoid perforation ^†	0/415 (0.00%)	0/419 (0.00%)	0/420 (0.00%)	1/421 (0.24%)	0/295 (0.00%)	0/289 (0.00%)
Subdural hematoma ^†	0/415 (0.00%)	0/419 (0.00%)	0/420 (0.00%)	0/421 (0.00%)	1/295 (0.34%)	0/289 (0.00%)
Unintentional overdose ^†	0/415 (0.00%)	1/419 (0.24%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Motor vehicle accident ^†	1/415 (0.24%)	0/419 (0.00%)	1/420 (0.24%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Metabolism and nutrition disorders
Electrolyte disturbance ^†	0/415 (0.00%)	1/419 (0.24%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Hypercalcemia ^†	1/415 (0.24%)	0/419 (0.00%)	0/420 (0.00%)	1/421 (0.24%)	0/295 (0.00%)	0/289 (0.00%)
Hyperglycemia ^†	0/415 (0.00%)	0/419 (0.00%)	0/420 (0.00%)	0/421 (0.00%)	2/295 (0.68%)	0/289 (0.00%)
Hyponatremia ^†	0/415 (0.00%)	1/419 (0.24%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Obesity ^†	0/415 (0.00%)	1/419 (0.24%)	0/420 (0.00%)	1/421 (0.24%)	0/295 (0.00%)	0/289 (0.00%)
Musculoskeletal and connective tissue disorders
Chest pain ^†	0/415 (0.00%)	1/419 (0.24%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Flat feet ^†	0/415 (0.00%)	0/419 (0.00%)	1/420 (0.24%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Fracture ^†	6/415 (1.45%)	2/419 (0.48%)	5/420 (1.19%)	2/421 (0.48%)	3/295 (1.02%)	5/289 (1.73%)
Gout/rheumatoid arthritis ^†	0/415 (0.00%)	1/419 (0.24%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Hernia ^†	1/415 (0.24%)	1/419 (0.24%)	0/420 (0.00%)	0/421 (0.00%)	1/295 (0.34%)	0/289 (0.00%)
Joint replacement ^†	5/415 (1.20%)	11/419 (2.63%)	21/420 (5.00%)	13/421 (3.09%)	10/295 (3.39%)	11/289 (3.81%)
Nerve entrapment ^†	0/415 (0.00%)	0/419 (0.00%)	1/420 (0.24%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Tendonitis ^†	0/415 (0.00%)	0/419 (0.00%)	1/420 (0.24%)	0/421 (0.00%)	0/295 (0.00%)	1/289 (0.35%)
Tenosynovitis ^†	0/415 (0.00%)	1/419 (0.24%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Traumatic injury ^†	2/415 (0.48%)	0/419 (0.00%)	1/420 (0.24%)	1/421 (0.24%)	1/295 (0.34%)	0/289 (0.00%)
Ventral hernia ^†	0/415 (0.00%)	0/419 (0.00%)	1/420 (0.24%)	1/421 (0.24%)	0/295 (0.00%)	0/289 (0.00%)
Back pain/degenerative spinal disorders ^†	5/415 (1.20%)	3/419 (0.72%)	4/420 (0.95%)	9/421 (2.14%)	3/295 (1.02%)	3/289 (1.04%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma ^†	0/415 (0.00%)	1/419 (0.24%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	1/289 (0.35%)
Benign parotid tumor ^†	0/415 (0.00%)	1/419 (0.24%)	0/420 (0.00%)	0/421 (0.00%)	1/295 (0.34%)	0/289 (0.00%)
Biliary cancer ^†	0/415 (0.00%)	0/419 (0.00%)	0/420 (0.00%)	1/421 (0.24%)	0/295 (0.00%)	0/289 (0.00%)
Bladder cancer ^†	0/415 (0.00%)	2/419 (0.48%)	1/420 (0.24%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Breast cancer/ductal carcinoma in situ ^† [1]	1/60 (1.67%)	3/63 (4.76%)	0/62 (0.00%)	0/67 (0.00%)	2/295 (0.68%)	2/289 (0.69%)
Carcinoid ^†	0/415 (0.00%)	0/419 (0.00%)	0/420 (0.00%)	1/421 (0.24%)	1/295 (0.34%)	1/289 (0.35%)
Central nervous system cancer ^†	0/415 (0.00%)	0/419 (0.00%)	1/420 (0.24%)	1/421 (0.24%)	0/295 (0.00%)	0/289 (0.00%)
Colorectal cancer ^†	0/415 (0.00%)	1/419 (0.24%)	0/420 (0.00%)	1/421 (0.24%)	1/295 (0.34%)	2/289 (0.69%)
Endometrial cancer/hyperplasia ^† [1]	2/60 (3.33%)	0/63 (0.00%)	0/62 (0.00%)	1/67 (1.49%)	2/295 (0.68%)	0/289 (0.00%)
Espohageal cancer ^†	0/415 (0.00%)	0/419 (0.00%)	1/420 (0.24%)	1/421 (0.24%)	0/295 (0.00%)	0/289 (0.00%)
Head and neck neoplasia ^†	0/415 (0.00%)	1/419 (0.24%)	0/420 (0.00%)	1/421 (0.24%)	0/295 (0.00%)	0/289 (0.00%)
Kidney cancer ^†	0/415 (0.00%)	1/419 (0.24%)	0/420 (0.00%)	1/421 (0.24%)	0/295 (0.00%)	0/289 (0.00%)
Lung cancer ^†	1/415 (0.24%)	2/419 (0.48%)	1/420 (0.24%)	0/421 (0.00%)	0/295 (0.00%)	1/289 (0.35%)
Lymphoma/leukemia ^†	3/415 (0.72%)	3/419 (0.72%)	1/420 (0.24%)	0/421 (0.00%)	1/295 (0.34%)	0/289 (0.00%)
Melanoma ^†	0/415 (0.00%)	3/419 (0.72%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Myeloma ^†	1/415 (0.24%)	0/419 (0.00%)	1/420 (0.24%)	1/421 (0.24%)	0/295 (0.00%)	0/289 (0.00%)
Oncocytoma ^†	1/415 (0.24%)	0/419 (0.00%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Ovarian cancer ^† [1]	1/60 (1.67%)	0/63 (0.00%)	0/62 (0.00%)	0/67 (0.00%)	1/295 (0.34%)	2/289 (0.69%)
Pancreatic cancer ^†	1/415 (0.24%)	0/419 (0.00%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Peritoneal mesothelioma ^†	0/415 (0.00%)	0/419 (0.00%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	1/289 (0.35%)
Prostate and bladder cancer ^† [2]	0/355 (0.00%)	1/356 (0.28%)	0/358 (0.00%)	0/354 (0.00%)	0/0	0/0
Prostate cancer ^† [2]	12/355 (3.38%)	12/356 (3.37%)	13/358 (3.63%)	6/354 (1.69%)	0/0	0/0
Serous ovarian tumor of low malignant potential ^† [1]	0/60 (0.00%)	1/63 (1.59%)	0/62 (0.00%)	0/67 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Skin basal cell carcinoma ^†	0/415 (0.00%)	0/419 (0.00%)	0/420 (0.00%)	0/421 (0.00%)	1/295 (0.34%)	0/289 (0.00%)
Thymoma type AB ^†	1/415 (0.24%)	0/419 (0.00%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Thyroid cancer ^†	1/415 (0.24%)	0/419 (0.00%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	1/289 (0.35%)
Nervous system disorders
Amyotrophic lateral sclerosis ^†	0/415 (0.00%)	1/419 (0.24%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Central nervous system cerebrovascular ischemia ^†	1/415 (0.24%)	0/419 (0.00%)	1/420 (0.24%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Cerebral spinal fluid leak ^†	1/415 (0.24%)	0/419 (0.00%)	0/420 (0.00%)	1/421 (0.24%)	0/295 (0.00%)	1/289 (0.35%)
Guillain-Barre syndrome ^†	0/415 (0.00%)	0/419 (0.00%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	1/289 (0.35%)
Hygroma ^†	0/415 (0.00%)	0/419 (0.00%)	1/420 (0.24%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Migraine syndrome ^†	1/415 (0.24%)	0/419 (0.00%)	0/420 (0.00%)	1/421 (0.24%)	0/295 (0.00%)	1/289 (0.35%)
Multiple sclerosis ^†	1/415 (0.24%)	0/419 (0.00%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Seizure ^†	0/415 (0.00%)	0/419 (0.00%)	0/420 (0.00%)	0/421 (0.00%)	2/295 (0.68%)	0/289 (0.00%)
Transient global amnesia ^†	0/415 (0.00%)	0/419 (0.00%)	1/420 (0.24%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Traumatic injury ^†	0/415 (0.00%)	1/419 (0.24%)	1/420 (0.24%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
^†	1/415 (0.24%)	1/419 (0.24%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Vertigo ^†	0/415 (0.00%)	1/419 (0.24%)	2/420 (0.48%)	0/421 (0.00%)	0/295 (0.00%)	1/289 (0.35%)
Vestibular neuritis ^†	0/415 (0.00%)	0/419 (0.00%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Psychiatric disorders
Bipolar affective disorder ^†	0/415 (0.00%)	1/419 (0.24%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Depression ^†	0/415 (0.00%)	1/419 (0.24%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	1/289 (0.35%)
Steroid psychosis ^†	1/415 (0.24%)	0/419 (0.00%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Renal and urinary disorders
Cystitis ^†	1/415 (0.24%)	0/419 (0.00%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Cystocele/rectocele ^†	0/415 (0.00%)	0/419 (0.00%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	2/289 (0.69%)
Hematuria ^†	0/415 (0.00%)	0/419 (0.00%)	1/420 (0.24%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Urolithiasis ^†	1/415 (0.24%)	3/419 (0.72%)	1/420 (0.24%)	2/421 (0.48%)	1/295 (0.34%)	1/289 (0.35%)
Renal failure ^†	0/415 (0.00%)	0/419 (0.00%)	0/420 (0.00%)	1/421 (0.24%)	0/295 (0.00%)	0/289 (0.00%)
Reproductive system and breast disorders
Benign prostatic hyperplasia ^† [2]	3/355 (0.85%)	5/356 (1.40%)	4/358 (1.12%)	1/354 (0.28%)	0/0	0/0
Breast surgery ^† [1]	0/60 (0.00%)	0/63 (0.00%)	0/62 (0.00%)	0/67 (0.00%)	3/295 (1.02%)	0/289 (0.00%)
Corpus luteum cyst ^† [1]	0/60 (0.00%)	0/63 (0.00%)	0/62 (0.00%)	0/67 (0.00%)	1/295 (0.34%)	0/289 (0.00%)
Fibroids ^† [1]	2/60 (3.33%)	0/63 (0.00%)	0/62 (0.00%)	0/67 (0.00%)	1/295 (0.34%)	1/289 (0.35%)
Pubovaginal sling ^† [1]	0/60 (0.00%)	0/63 (0.00%)	0/62 (0.00%)	0/67 (0.00%)	1/295 (0.34%)	0/289 (0.00%)
Uterine prolapse ^† [1]	0/60 (0.00%)	0/63 (0.00%)	0/62 (0.00%)	1/67 (1.49%)	1/295 (0.34%)	1/289 (0.35%)
Vaginal bleeding ^† [1]	0/60 (0.00%)	1/63 (1.59%)	0/62 (0.00%)	0/67 (0.00%)	1/295 (0.34%)	0/289 (0.00%)
Vaginal prolapse ^† [1]	0/60 (0.00%)	0/63 (0.00%)	1/62 (1.61%)	0/67 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Respiratory, thoracic and mediastinal disorders
Asthma ^†	0/415 (0.00%)	0/419 (0.00%)	1/420 (0.24%)	0/421 (0.00%)	1/295 (0.34%)	0/289 (0.00%)
Chronic obstructive pulmonary disease ^†	1/415 (0.24%)	1/419 (0.24%)	0/420 (0.00%)	0/421 (0.00%)	1/295 (0.34%)	3/289 (1.04%)
Malignant pleural effusion ^†	1/415 (0.24%)	0/419 (0.00%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Pneumonitis ^†	0/415 (0.00%)	2/419 (0.48%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Pulmonary fibrosis ^†	0/415 (0.00%)	1/419 (0.24%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Traumatic injury ^†	2/415 (0.48%)	0/419 (0.00%)	0/420 (0.00%)	1/421 (0.24%)	0/295 (0.00%)	0/289 (0.00%)
Skin and subcutaneous tissue disorders
Cosmetic surgery ^†	1/415 (0.24%)	0/419 (0.00%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Vascular disorders
Aneurysm ^†	0/415 (0.00%)	0/419 (0.00%)	1/420 (0.24%)	0/421 (0.00%)	0/295 (0.00%)	1/289 (0.35%)
Cerebrovascular ischemia ^†	1/415 (0.24%)	0/419 (0.00%)	3/420 (0.71%)	3/421 (0.71%)	3/295 (1.02%)	4/289 (1.38%)
Hypotension ^†	0/415 (0.00%)	1/419 (0.24%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Phlebitis ^†	0/415 (0.00%)	0/419 (0.00%)	0/420 (0.00%)	0/421 (0.00%)	1/295 (0.34%)	0/289 (0.00%)
Revascularization ^†	3/415 (0.72%)	7/419 (1.67%)	3/420 (0.71%)	6/421 (1.43%)	1/295 (0.34%)	4/289 (1.38%)
Subdural hematoma ^†	0/415 (0.00%)	0/419 (0.00%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	1/289 (0.35%)
Sudden death ^†	0/415 (0.00%)	0/419 (0.00%)	0/420 (0.00%)	1/421 (0.24%)	0/295 (0.00%)	0/289 (0.00%)
Traumatic injury ^†	1/415 (0.24%)	0/419 (0.00%)	0/420 (0.00%)	0/421 (0.00%)	0/295 (0.00%)	0/289 (0.00%)
Venous thromboembolism ^†	1/415 (0.24%)	2/419 (0.48%)	6/420 (1.43%)	1/421 (0.24%)	1/295 (0.34%)	1/289 (0.35%)
† Indicates events were collected by systematic assessment [1] Only women are considered at risk [2] Only men are considered at risk
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Full Factorial Placebo	Full Factorial Calcium	Full Factorial Vitamin D	Full Factorial Calcium Plus Vitamin D	Two Arm Placebo	Two Arm Vitamin D
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	46/415 (11.08%)	45/419 (10.74%)	47/420 (11.19%)	61/421 (14.49%)	53/295 (17.97%)	40/289 (13.84%)
Musculoskeletal and connective tissue disorders
Fracture ^†	15/415 (3.61%)	12/419 (2.86%)	15/420 (3.57%)	21/421 (4.99%)	22/295 (7.46%)	7/289 (2.42%)
Osteopenia ^†	5/415 (1.20%)	8/419 (1.91%)	6/420 (1.43%)	7/421 (1.66%)	17/295 (5.76%)	16/289 (5.54%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-melanoma skin cancer ^†	20/415 (4.82%)	26/419 (6.21%)	22/420 (5.24%)	28/421 (6.65%)	11/295 (3.73%)	11/289 (3.81%)
Renal and urinary disorders
Hypercreatinemia ^† [1]	21/407 (5.16%)	29/412 (7.04%)	19/415 (4.58%)	29/413 (7.02%)	17/294 (5.78%)	9/287 (3.14%)
† Indicates events were collected by systematic assessment [1] Hypercreatinemia is a value on a safety blood draw above normal for subjects whose baseline creatinine was normal. Only subjects who had at least one safety blood draw are included.

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Leila A. Mott, Statistical Analyst
Organization:	Geisel School of Medicine at Dartmouth
Phone:	603-650-3447
EMail:	Leila.A.Mott@Dartmouth.EDU

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Passarelli MN, Mott LA, Barry EL, Rees JR, Baron JA. Oral Antibiotics and Risk of New Colorectal Adenomas During Surveillance Follow-up. Cancer Epidemiol Biomarkers Prev. 2021 Oct;30(10):1974-1976. doi: 10.1158/1055-9965.EPI-21-0323. Epub 2021 Jul 21.

Passarelli MN, Karagas MR, Mott LA, Rees JR, Barry EL, Baron JA. Risk of keratinocyte carcinomas with vitamin D and calcium supplementation: a secondary analysis of a randomized clinical trial. Am J Clin Nutr. 2020 Dec 10;112(6):1532-1539. doi: 10.1093/ajcn/nqaa267.

Crockett SD, Barry EL, Mott LA, Ahnen DJ, Robertson DJ, Anderson JC, Wallace K, Burke CA, Bresalier RS, Figueiredo JC, Snover DC, Baron JA. Calcium and vitamin D supplementation and increased risk of serrated polyps: results from a randomised clinical trial. Gut. 2019 Mar;68(3):475-486. doi: 10.1136/gutjnl-2017-315242. Epub 2018 Mar 1.

Anderson JC, Morris CB, Robertson DJ, Barry ELR, Figueiredo JC, Cruz-Correa M, Bostick RM, Ahnen DJ, Baron JA. Can the Sum of Adenoma Diameters (Adenoma Bulk) on Index Examination Predict Risk of Metachronous Advanced Neoplasia? J Clin Gastroenterol. 2018 Aug;52(7):628-634. doi: 10.1097/MCG.0000000000000899.

Barry EL, Peacock JL, Rees JR, Bostick RM, Robertson DJ, Bresalier RS, Baron JA. Vitamin D Receptor Genotype, Vitamin D3 Supplementation, and Risk of Colorectal Adenomas: A Randomized Clinical Trial. JAMA Oncol. 2017 May 1;3(5):628-635. doi: 10.1001/jamaoncol.2016.5917.

Rees JR, Mott LA, Barry EL, Baron JA, Bostick RM, Figueiredo JC, Bresalier RS, Robertson DJ, Peacock JL. Lifestyle and Other Factors Explain One-Half of the Variability in the Serum 25-Hydroxyvitamin D Response to Cholecalciferol Supplementation in Healthy Adults. J Nutr. 2016 Nov;146(11):2312-2324. doi: 10.3945/jn.116.236323. Epub 2016 Sep 28.

Rees JR, Mott LA, Barry EL, Baron JA, Figueiredo JC, Robertson DJ, Bresalier RS, Peacock JL. Randomized controlled trials: who fails run-in? Trials. 2016 Jul 29;17:374. doi: 10.1186/s13063-016-1451-9.

Baron JA, Barry EL, Mott LA, Rees JR, Sandler RS, Snover DC, Bostick RM, Ivanova A, Cole BF, Ahnen DJ, Beck GJ, Bresalier RS, Burke CA, Church TR, Cruz-Correa M, Figueiredo JC, Goodman M, Kim AS, Robertson DJ, Rothstein R, Shaukat A, Seabrook ME, Summers RW. A Trial of Calcium and Vitamin D for the Prevention of Colorectal Adenomas. N Engl J Med. 2015 Oct 15;373(16):1519-30. doi: 10.1056/NEJMoa1500409.

Barry EL, Mott LA, Melamed ML, Rees JR, Ivanova A, Sandler RS, Ahnen DJ, Bresalier RS, Summers RW, Bostick RM, Baron JA. Calcium supplementation increases blood creatinine concentration in a randomized controlled trial. PLoS One. 2014 Oct 15;9(10):e108094. doi: 10.1371/journal.pone.0108094. eCollection 2014.

Barry EL, Rees JR, Peacock JL, Mott LA, Amos CI, Bostick RM, Figueiredo JC, Ahnen DJ, Bresalier RS, Burke CA, Baron JA. Genetic variants in CYP2R1, CYP24A1, and VDR modify the efficacy of vitamin D3 supplementation for increasing serum 25-hydroxyvitamin D levels in a randomized controlled trial. J Clin Endocrinol Metab. 2014 Oct;99(10):E2133-7. doi: 10.1210/jc.2014-1389. Epub 2014 Jul 29.

Rees JR, Hendricks K, Barry EL, Peacock JL, Mott LA, Sandler RS, Bresalier RS, Goodman M, Bostick RM, Baron JA. Vitamin D3 supplementation and upper respiratory tract infections in a randomized, controlled trial. Clin Infect Dis. 2013 Nov;57(10):1384-92. doi: 10.1093/cid/cit549. Epub 2013 Sep 6.

Bischoff-Ferrari HA, Rees JR, Grau MV, Barry E, Gui J, Baron JA. Effect of calcium supplementation on fracture risk: a double-blind randomized controlled trial. Am J Clin Nutr. 2008 Jun;87(6):1945-51. doi: 10.1093/ajcn/87.6.1945.

Layout table for additonal information

Responsible Party:	Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:	NCT00153816
Other Study ID Numbers:	5R01CA098286-03 ( U.S. NIH Grant/Contract ) 5R01CA098286-10 ( U.S. NIH Grant/Contract )
First Submitted:	September 7, 2005
First Posted:	September 12, 2005
Results First Submitted:	September 21, 2015
Results First Posted:	October 20, 2015
Last Update Posted:	March 15, 2017

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