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Randomized Trial: Maternal Vitamin D Supplementation to Prevent Childhood Asthma (VDAART) (VDAART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00920621

Recruitment Status : Active, not recruiting

First Posted : June 15, 2009

Results First Posted : July 14, 2017

Last Update Posted : July 20, 2023

View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborator:

National Heart, Lung, and Blood Institute (NHLBI)

Information provided by (Responsible Party):

Scott T. Weiss, Brigham and Women's Hospital

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention
Condition	Asthma
Interventions	Dietary Supplement: Vitamin D 3 cholecalciferol Dietary Supplement: Vitamin D3
Enrollment	876

Participant Flow

Recruitment Details	VDAART was a randomized, double-blind, placebo-controlled trial. Enrollment began October 2009 and completed follow-up January 2015 in 3 medical centers in the United Stated. 881 pregnant women age 18-39 at high risk for having children with asthma were randomized at 10-18 weeks gestation. 5 did not meet inclusion criteria and were removed.
Pre-assignment Details


Arm/Group Title	Vitamin D Treatment (Mothers)	Placebo (Mothers)	Vitamin D Treatment (Offspring)	Placebo (Offspring)
Arm/Group Description	Mothers' assigned to vitamin D (dai...	Mothers' assigned to placebo (daily...	Offspring of mothers' assigned to v...	Offspring of mothers' assigned to p...
Arm/Group Description	Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).	Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy).	Offspring of mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D)	Offspring of mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control"
Period Title: Overall Study
Started	440	436	440	436
Completed	386	391	405	401
Not Completed	54	45	35	35
Reason Not Completed
Lost to Follow-up	16	17	19	21
Fetal/neonatal deaths	16	14	16	14
Blood sample not collected	22	14	0	0

Baseline Characteristics

Arm/Group Title		Vitamin D Treatment (Mothers)	Placebo (Mothers)	Vitamin D Treatment (Children)	Placebo (Children)	Total
Arm/Group Description		Mothers' assigned to vitamin D (dai...	Mothers' assigned to placebo (daily...	Children of mothers' assigned to vi...	Children of mothers' assigned to pl...	Total of all reporting groups
Arm/Group Description		Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D)	Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy).	Children of mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).	Children of mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy).	Total of all reporting groups
Overall Number of Baseline Participants		440	436	405	401	1682
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	440 participants	436 participants	405 participants	401 participants	1682 participants
		27.5 (5.5)	27.3 (5.6)	0 (0)	0 (0)	27.4 (5.6)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	440 participants	436 participants	405 participants	401 participants	1682 participants
	Female	440 100.0%	436 100.0%	204 50.4%	181 45.1%	1261 75.0%
	Male	0 0.0%	0 0.0%	201 49.6%	220 54.9%	421 25.0%
Race/Ethnicity, Customized Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	440 participants	436 participants	405 participants	401 participants	1682 participants
Black		190 43.2%	190 43.6%	199 49.1%	191 47.6%	770 45.8%
White Hispanic		59 13.4%	61 14.0%	53 13.1%	51 12.7%	224 13.3%
White non-Hispanic		114 25.9%	116 26.6%	82 20.2%	79 19.7%	391 23.2%
Other		77 17.5%	69 15.8%	71 17.5%	80 20.0%	297 17.7%

Outcome Measures

1.Primary Outcome


Title	Asthma or Recurrent Wheeze in First 3 Years of Life
Description	Parental report of physician diagnosis of asthma or occurrence of recu...
Description	Parental report of physician diagnosis of asthma or occurrence of recurrent wheeze in the child's first 3 years of life ascertained from questionnaires administered every 3 months. *For some variables the "negative" count incorporates "negative and indeterminate."
Time Frame	First 3 years of life.

Outcome Measure Data

Analysis Population Description

Some measures have missing data due to collection, technical, and processing issues.


Arm/Group Title	Vitamin D Treatment	Placebo
Arm/Group Description:	Children of mother's assigned 4400 ...	Children of mother's assigned 400 I...
Arm/Group Description:	Children of mother's assigned 4400 IU Vitamin D	Children of mother's assigned 400 IU Vitamin D.
Overall Number of Participants Analyzed	405	401
Measure Type: Count of Participants Unit of Measure: Participants
Children positive	98 24.2%	120 29.9%
Children negative	307 75.8%	281 70.1%

2.Primary Outcome


Title	Achieved Maternal 25(OH)D Level of ≥ 30 ng/mL at Third Trimester Sampling.
Description	Maternal serum 25-hydroxyvitamin D measurement at third trimester duri...
Description	Maternal serum 25-hydroxyvitamin D measurement at third trimester during pregnancy
Time Frame	32-38 weeks gestation

Outcome Measure Data

Analysis Population Description

Some measures have missing data due to collection, technical, and processing issues.


Arm/Group Title	Vitamin D Treatment	Placebo
Arm/Group Description:	Mothers' assigned to vitamin D (dai...	Mothers' assigned to placebo (daily...
Arm/Group Description:	Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).	Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy).
Overall Number of Participants Analyzed	386	391
Measure Type: Count of Participants Unit of Measure: Participants
25(OH)D level of ≥ 30 ng/mL , women positive	289 74.9%	133 34.0%
25(OH)D level of ≥ 30 ng/mL , women negative	97 25.1%	258 66.0%

3.Secondary Outcome


Title	Child Positive-specific IgE Tests From Blood Collection at 3 Year Visit.
Description	Child positive-specific IgE tests from blood collection at 3 year visi...
Description	Child positive-specific IgE tests from blood collection at 3 year visit.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Some measures have missing data due to collection, technical, and processing issues.


Arm/Group Title	Vitamin D Treatment	Placebo
Arm/Group Description:	Children of mother's assigned 4400 ...	Children of mother's assigned 400 I...
Arm/Group Description:	Children of mother's assigned 4400 IU Vitamin D	Children of mother's assigned 400 IU Vitamin D.
Overall Number of Participants Analyzed	278	263
Overall Number of Units Analyzed Type of Units Analyzed: Completed tests	3876	3651
Measure Type: Number Unit of Measure: Positive-specific IgE tests
	414	452

4.Secondary Outcome


Title	Child Serum 25-hydroxyvitamin D Measurement From Blood Collection at 1 Year Visit.
Description	Child serum 25-hydroxyvitamin D measurement from blood collection at 1...
Description	Child serum 25-hydroxyvitamin D measurement from blood collection at 1 year visit.
Time Frame	1 year visit

Outcome Measure Data

Analysis Population Description

Some measures have missing data due to collection, technical, and processing issues.


Arm/Group Title	Vitamin D Treatment	Placebo
Arm/Group Description:	Children of mother's assigned 4400 ...	Children of mother's assigned 400 I...
Arm/Group Description:	Children of mother's assigned 4400 IU Vitamin D	Children of mother's assigned 400 IU Vitamin D.
Overall Number of Participants Analyzed	322	309
Mean (Standard Deviation) Unit of Measure: ng/mL
	29.3 (9.2)	30.1 (10.8)

5.Secondary Outcome


Title	Parental Report of Physician Diagnosed Eczema (With Rash) in the Child's First 3 Years of Life.
Description	Parental report of physician diagnosis of eczema with rash in typical ...
Description	Parental report of physician diagnosis of eczema with rash in typical distribution in the child's first 3 years of life ascertained from questionnaires administered every 3 months. *For some variables the "negative" count incorporates "negative and indeterminate."
Time Frame	Child's first 3 years of life.

Outcome Measure Data

Analysis Population Description

Some measures have missing data due to collection, technical, and processing issues.


Arm/Group Title	Vitamin D Treatment	Placebo
Arm/Group Description:	Children of mother's assigned 4400 ...	Children of mother's assigned 400 I...
Arm/Group Description:	Children of mother's assigned 4400 IU Vitamin D	Children of mother's assigned 400 IU Vitamin D.
Overall Number of Participants Analyzed	405	401
Measure Type: Count of Participants Unit of Measure: Participants
Children positive	83 20.5%	89 22.2%
Children negative	322 79.5%	312 77.8%

6.Secondary Outcome


Title	Parental Report of Physician Diagnosis of Lower Respiratory Tract Infection in the Child's First 3 Years of Life.
Description	Parental report of physician diagnosis of lower respiratory tract infe...
Description	Parental report of physician diagnosis of lower respiratory tract infection (LRI) in the child's first 3 years of life. LRI defined as physician diagnosed bronchitis, bronchiolitis, croup, or pneumonia ascertained from questionnaires administered every 3 months.
Time Frame	Child's first 3 years of life.

Outcome Measure Data

Analysis Population Description

Some measures have missing data due to collection, technical, and processing issues.


Arm/Group Title	Vitamin D Treatment	Placebo
Arm/Group Description:	Children of mother's assigned 4400 ...	Children of mother's assigned 400 I...
Arm/Group Description:	Children of mother's assigned 4400 IU Vitamin D	Children of mother's assigned 400 IU Vitamin D.
Overall Number of Participants Analyzed	405	401
Measure Type: Number Unit of Measure: Number of lower respiratory infections
	222	276

7.Secondary Outcome


Title	Child Serum 25-hydroxyvitamin D Measurement From Blood Collection at 3 Year Visit.
Description	Child serum 25-hydroxyvitamin D measurement from blood collection at 3...
Description	Child serum 25-hydroxyvitamin D measurement from blood collection at 3 year visit.
Time Frame	Blood collection at childs' 3 year visit.

Outcome Measure Data

Analysis Population Description

Some measures have missing data due to collection, technical, and processing issues.


Arm/Group Title	Vitamin D Treatment	Placebo
Arm/Group Description:	Children of mother's assigned 4400 ...	Children of mother's assigned 400 I...
Arm/Group Description:	Children of mother's assigned 4400 IU Vitamin D	Children of mother's assigned 400 IU Vitamin D.
Overall Number of Participants Analyzed	289	271
Mean (Standard Deviation) Unit of Measure: ng/mL
	21.3 (10.4)	21.5 (8.5)

8.Secondary Outcome


Title	Any Allergic Sensitization in the Child's First 3 Years of Life.
Description	Any allergic sensitization in the child's first 3 years of life. ...
Description	Any allergic sensitization in the child's first 3 years of life. *For some variables the "negative" count incorporates "negative and indeterminate."
Time Frame	Child's first 3 years of life.

Outcome Measure Data

Analysis Population Description

Some measures have missing data due to collection, technical, and processing issues.


Arm/Group Title	Vitamin D Treatment	Placebo
Arm/Group Description:	Children of mother's assigned 4400 ...	Children of mother's assigned 400 I...
Arm/Group Description:	Children of mother's assigned 4400 IU Vitamin D	Children of mother's assigned 400 IU Vitamin D.
Overall Number of Participants Analyzed	278	261
Measure Type: Count of Participants Unit of Measure: Participants
Any sensitization	146 52.5%	144 55.2%
No sensitization	132 47.5%	117 44.8%

9.Secondary Outcome


Title	Mass Spec Vitamin D Value From Cord Blood at Delivery
Description	Mass Spec Vitamin D value from cord blood at delivery
Description	Mass Spec Vitamin D value from cord blood at delivery
Time Frame	Blood collection at delivery

Outcome Measure Data

Analysis Population Description

Some measures have missing data due to collection, technical, and processing issues.


Arm/Group Title	Vitamin D Treatment	Placebo
Arm/Group Description:	Mothers' assigned to vitamin D (dai...	Mothers' assigned to placebo (daily...
Arm/Group Description:	Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).	Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy).
Overall Number of Participants Analyzed	303	316
Mean (Standard Deviation) Unit of Measure: ng/mL
	28.2 (12.4)	19.1 (9.7)

10.Secondary Outcome


Title	Sphingolipid Profile
Description	Mass spec measured relative abundance of five metabolites of the sphin...
Description	Mass spec measured relative abundance of five metabolites of the sphingolipid metabolism pathway in plasma samples extracted at the year one visit.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Some measures have missing data due to collection, technical, and processing issues.


Arm/Group Title	Vitamin D Treatment	Placebo
Arm/Group Description:	Children of mother's assigned 4400 ...	Children of mother's assigned 400 I...
Arm/Group Description:	Children of mother's assigned 4400 IU Vitamin D	Children of mother's assigned 400 IU Vitamin D
Overall Number of Participants Analyzed	211	202
Mean (Standard Deviation) Unit of Measure: relative abundance (no units)
sphinganine-1-phosphate	0.32 (0.10)	0.32 (0.10)
sphinganine	0.33 (0.20)	0.31 (0.18)
phosphoethanolamine	0.33 (0.13)	0.34 (0.13)
sphingosine	0.34 (0.17)	0.33 (0.17)
sphingosine-1-phosphate	0.31 (0.06)	0.32 (0.06)

11.Secondary Outcome


Title	Sphingolipid Profile
Description	Mass spec measured relative abundance of five metabolites of the sphin...
Description	Mass spec measured relative abundance of five metabolites of the sphingolipid metabolism pathway in plasma samples extracted at the year three visit.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Some measures have missing data due to collection, technical, and processing issues.


Arm/Group Title	Vitamin D Treatment	Placebo
Arm/Group Description:	Children of mother's assigned 4400 ...	Children of mother's assigned 400 I...
Arm/Group Description:	Children of mother's assigned 4400 IU Vitamin D	Children of mother's assigned 400 IU Vitamin D
Overall Number of Participants Analyzed	179	174
Mean (Standard Deviation) Unit of Measure: relative abundance (no units)
sphinganine-1-phosphate	0.34 (0.12)	0.32 (0.12)
sphinganine	0.39 (0.20)	0.37 (0.20)
phosphoethanolamine	0.31 (0.11)	0.30 (0.11)
sphingosine	0.38 (0.19)	0.37 (0.19)
sphingosine-1-phosphate	0.31 (0.07)	0.30 (0.08)

12.Secondary Outcome


Title	Child 17q21 Genotype
Description	Genotype at the rs12936231 SNP
Description	Genotype at the rs12936231 SNP
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Some measures have missing data due to collection, technical, and processing issues.


Arm/Group Title	Vitamin D Treatment	Placebo
Arm/Group Description:	Children of mother's assigned 4400 ...	Children of mother's assigned 400 I...
Arm/Group Description:	Children of mother's assigned 4400 IU Vitamin D	Children of mother's assigned 400 IU Vitamin D
Overall Number of Participants Analyzed	311	307
Measure Type: Count of Participants Unit of Measure: Participants
CC	93 29.9%	78 25.4%
GC	152 48.9%	161 52.4%
GG	66 21.2%	68 22.1%

13.Secondary Outcome


Title	Fecal Microbiome Profile
Description	We extracted DNA and sequenced the bacterial 16S V4 hyper-variable reg...
Description	We extracted DNA and sequenced the bacterial 16S V4 hyper-variable region. The average number of 16S region reads sequenced per participant is provided here. Prior evidence suggests that read counts of at least 1,000 are adequate for 16S fecal microbiome profiling (Reference: Momozawa Y, et cal. Characterization of bacteria in biopsies of colon and stools by high throughput sequencing of the V2 region of bacterial 16S rRNA gene in human. PLoS One. 2011 Feb 10;6(2):e16952.)
Time Frame	Mother at 32-38 weeks gestation, Child's first 6 years of life

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Vitamin D Treatment	Placebo
Arm/Group Description:	Mothers' assigned to vitamin D (dai...	Mothers' assigned to placebo (daily...
Arm/Group Description:	Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).	Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy).
Overall Number of Participants Analyzed	335	332
Overall Number of Units Analyzed Type of Units Analyzed: Samples	696	631
Mean (Standard Deviation) Unit of Measure: read counts
Mother at 32-38 weeks gestation	10787 (3534)	10773 (2511)
Child at 3-6 months	13443 (8624)	14024 (9010)
Child at 1 year	11709 (4202)	11635 (3488)
Child at 3 years	12095 (4733)	12407 (4288)
Child at 4 years	0 (0)	0 (0)
Child at 5 years	0 (0)	0 (0)
Child at 6 years	0 (0)	0 (0)

Adverse Events

Time Frame	From the point mothers entered the study until 2 years post delivery.
Adverse Event Reporting Description	Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.

Arm/Group Title	Vitamin D Treatment (Mothers)		Placebo (Mothers)		Vitamin D Treatment (Offspring)		Placebo (Offspring)
Arm/Group Description	Mothers' assigned to vitamin D (dai...		Mothers' assigned to placebo (daily...		Offspring of mothers' assigned to v...		Offspring of mothers' assigned to p...
Arm/Group Description	Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).		Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy).		Offspring of mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).		Offspring of mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy).
All-Cause Mortality
	Vitamin D Treatment (Mothers)		Placebo (Mothers)		Vitamin D Treatment (Offspring)		Placebo (Offspring)
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	0/440 (0.00%)		1/436 (0.23%)		3/440 (0.68%)		3/436 (0.69%)
Serious Adverse Events Serious Adverse Events
	Vitamin D Treatment (Mothers)		Placebo (Mothers)		Vitamin D Treatment (Offspring)		Placebo (Offspring)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	75/440 (17.05%)		77/436 (17.66%)		58/440 (13.18%)		52/436 (11.93%)
General disorders
Hospitalization ^†	32/440 (7.27%)	42	32/436 (7.34%)	45	0/440 (0.00%)	0	0/436 (0.00%)	0
Postpartum Hospitalization ^†	7/440 (1.59%)	10	6/436 (1.38%)	8	0/440 (0.00%)	0	0/436 (0.00%)	0
Maternal Death ^†	0/440 (0.00%)	0	1/436 (0.23%)	1	0/440 (0.00%)	0	0/436 (0.00%)	0
NICU ^† [1]	0/440 (0.00%)	0	0/436 (0.00%)	0	29/440 (6.59%)	36	18/436 (4.13%)	28
Pregnancy, puerperium and perinatal conditions
HELLP ^†	2/440 (0.45%)	2	1/436 (0.23%)	1	0/440 (0.00%)	0	0/436 (0.00%)	0
Preeclampsia ^†	34/440 (7.73%)	36	37/436 (8.49%)	38	0/440 (0.00%)	0	0/436 (0.00%)	0
Pre-term delivery <32 weeks gestation ^†	0/440 (0.00%)	0	0/436 (0.00%)	0	3/440 (0.68%)	5	7/436 (1.61%)	11
Major fetal or congenital anomaly ^†	0/440 (0.00%)	0	0/436 (0.00%)	0	10/440 (2.27%)	17	13/436 (2.98%)	14
Still birth or intrauterine fetal death ^†	0/440 (0.00%)	0	0/436 (0.00%)	0	13/440 (2.95%)	13	11/436 (2.52%)	11
Neonatal demise ^†	0/440 (0.00%)	0	0/436 (0.00%)	0	3/440 (0.68%)	3	3/436 (0.69%)	3
† Indicates events were collected by systematic assessment [1] Neonatal ICU admission
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Vitamin D Treatment (Mothers)		Placebo (Mothers)		Vitamin D Treatment (Offspring)		Placebo (Offspring)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/440 (0.00%)		0/436 (0.00%)		0/440 (0.00%)		0/436 (0.00%)

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:	Scott T. Weiss, MD, MS
Organization:	Brigham and Women's Hospital
Phone:	617-525-2278
EMail:	scott.weiss@channing.harvard.edu

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

Knihtila HM, Kelly RS, Brustad N, Huang M, Kachroo P, Chawes BL, Stokholm J, Bonnelykke K, Pedersen CT, Bisgaard H, Litonjua AA, Lasky-Su JA, Weiss ST. Maternal 17q21 genotype influences prenatal vitamin D effects on offspring asthma/recurrent wheeze. Eur Respir J. 2021 Sep 23;58(3):2002012. doi: 10.1183/13993003.02012-2020. Print 2021 Sep.

Litonjua AA, Carey VJ, Laranjo N, Stubbs BJ, Mirzakhani H, O'Connor GT, Sandel M, Beigelman A, Bacharier LB, Zeiger RS, Schatz M, Hollis BW, Weiss ST. Six-Year Follow-up of a Trial of Antenatal Vitamin D for Asthma Reduction. N Engl J Med. 2020 Feb 6;382(6):525-533. doi: 10.1056/NEJMoa1906137.

Lu M, Hollis BW, Carey VJ, Laranjo N, Singh RJ, Weiss ST, Litonjua AA. Determinants and Measurement of Neonatal Vitamin D: Overestimation of 25(OH)D in Cord Blood Using CLIA Assay Technology. J Clin Endocrinol Metab. 2020 Apr 1;105(4):e1085-92. doi: 10.1210/clinem/dgz299.

Lee-Sarwar KA, Kelly RS, Lasky-Su J, Zeiger RS, O'Connor GT, Sandel MT, Bacharier LB, Beigelman A, Rifas-Shiman SL, Carey VJ, Harshfield BJ, Laranjo N, Gold DR, Weiss ST, Litonjua AA. Fecal short-chain fatty acids in pregnancy and offspring asthma and allergic outcomes. J Allergy Clin Immunol Pract. 2020 Mar;8(3):1100-1102.e13. doi: 10.1016/j.jaip.2019.08.036. Epub 2019 Sep 5. No abstract available.

Yu B, Zanetti KA, Temprosa M, Albanes D, Appel N, Barrera CB, Ben-Shlomo Y, Boerwinkle E, Casas JP, Clish C, Dale C, Dehghan A, Derkach A, Eliassen AH, Elliott P, Fahy E, Gieger C, Gunter MJ, Harada S, Harris T, Herr DR, Herrington D, Hirschhorn JN, Hoover E, Hsing AW, Johansson M, Kelly RS, Khoo CM, Kivimaki M, Kristal BS, Langenberg C, Lasky-Su J, Lawlor DA, Lotta LA, Mangino M, Le Marchand L, Mathe E, Matthews CE, Menni C, Mucci LA, Murphy R, Oresic M, Orwoll E, Ose J, Pereira AC, Playdon MC, Poston L, Price J, Qi Q, Rexrode K, Risch A, Sampson J, Seow WJ, Sesso HD, Shah SH, Shu XO, Smith GCS, Sovio U, Stevens VL, Stolzenberg-Solomon R, Takebayashi T, Tillin T, Travis R, Tzoulaki I, Ulrich CM, Vasan RS, Verma M, Wang Y, Wareham NJ, Wong A, Younes N, Zhao H, Zheng W, Moore SC. The Consortium of Metabolomics Studies (COMETS): Metabolomics in 47 Prospective Cohort Studies. Am J Epidemiol. 2019 Jun 1;188(6):991-1012. doi: 10.1093/aje/kwz028.

Lee-Sarwar KA, Kelly RS, Lasky-Su J, Zeiger RS, O'Connor GT, Sandel MT, Bacharier LB, Beigelman A, Laranjo N, Gold DR, Weiss ST, Litonjua AA. Integrative analysis of the intestinal metabolome of childhood asthma. J Allergy Clin Immunol. 2019 Aug;144(2):442-454. doi: 10.1016/j.jaci.2019.02.032. Epub 2019 Mar 23.

Mirzakhani H, Carey VJ, Zeiger R, Bacharier LB, O'Connor GT, Schatz MX, Laranjo N, Weiss ST, Litonjua AA. Impact of parental asthma, prenatal maternal asthma control, and vitamin D status on risk of asthma and recurrent wheeze in 3-year-old children. Clin Exp Allergy. 2019 Apr;49(4):419-429. doi: 10.1111/cea.13320. Epub 2019 Jan 3.

Savage JH, Lee-Sarwar KA, Sordillo JE, Lange NE, Zhou Y, O'Connor GT, Sandel M, Bacharier LB, Zeiger R, Sodergren E, Weinstock GM, Gold DR, Weiss ST, Litonjua AA. Diet during Pregnancy and Infancy and the Infant Intestinal Microbiome. J Pediatr. 2018 Dec;203:47-54.e4. doi: 10.1016/j.jpeds.2018.07.066. Epub 2018 Aug 30.

Mirzakhani H, Carey VJ, McElrath TF, Qiu W, Hollis BW, O'Connor GT, Zeiger RS, Bacharier L, Litonjua AA, Weiss ST. Impact of Preeclampsia on the Relationship between Maternal Asthma and Offspring Asthma. An Observation from the VDAART Clinical Trial. Am J Respir Crit Care Med. 2019 Jan 1;199(1):32-42. doi: 10.1164/rccm.201804-0770OC.

Mirzakhani H, Al-Garawi AA, Carey VJ, Qiu W, Litonjua AA, Weiss ST. Expression network analysis reveals cord blood vitamin D-associated genes affecting risk of early life wheeze. Thorax. 2019 Feb;74(2):200-202. doi: 10.1136/thoraxjnl-2018-211962. Epub 2018 Jul 18.

Kelly RS, Sordillo JE, Lasky-Su J, Dahlin A, Perng W, Rifas-Shiman SL, Weiss ST, Gold DR, Litonjua AA, Hivert MF, Oken E, Wu AC. Plasma metabolite profiles in children with current asthma. Clin Exp Allergy. 2018 Oct;48(10):1297-1304. doi: 10.1111/cea.13183. Epub 2018 Jul 3.

Wolsk HM, Chawes BL, Litonjua AA, Hollis BW, Waage J, Stokholm J, Bonnelykke K, Bisgaard H, Weiss ST. Prenatal vitamin D supplementation reduces risk of asthma/recurrent wheeze in early childhood: A combined analysis of two randomized controlled trials. PLoS One. 2017 Oct 27;12(10):e0186657. doi: 10.1371/journal.pone.0186657. eCollection 2017.

Blighe K, Chawes BL, Kelly RS, Mirzakhani H, McGeachie M, Litonjua AA, Weiss ST, Lasky-Su JA. Vitamin D prenatal programming of childhood metabolomics profiles at age 3 y. Am J Clin Nutr. 2017 Oct;106(4):1092-1099. doi: 10.3945/ajcn.117.158220. Epub 2017 Aug 23.

Mirzakhani H, O'Connor G, Bacharier LB, Zeiger RS, Schatz MX, Weiss ST, Litonjua AA. Asthma control status in pregnancy, body mass index, and maternal vitamin D levels. J Allergy Clin Immunol. 2017 Nov;140(5):1453-1456.e7. doi: 10.1016/j.jaci.2017.03.053. Epub 2017 Jun 9.

Hornsby E, Pfeffer PE, Laranjo N, Cruikshank W, Tuzova M, Litonjua AA, Weiss ST, Carey VJ, O'Connor G, Hawrylowicz C. Vitamin D supplementation during pregnancy: Effect on the neonatal immune system in a randomized controlled trial. J Allergy Clin Immunol. 2018 Jan;141(1):269-278.e1. doi: 10.1016/j.jaci.2017.02.039. Epub 2017 May 26.

Mirzakhani H, Litonjua AA, McElrath TF, O'Connor G, Lee-Parritz A, Iverson R, Macones G, Strunk RC, Bacharier LB, Zeiger R, Hollis BW, Handy DE, Sharma A, Laranjo N, Carey V, Qiu W, Santolini M, Liu S, Chhabra D, Enquobahrie DA, Williams MA, Loscalzo J, Weiss ST. Early pregnancy vitamin D status and risk of preeclampsia. J Clin Invest. 2016 Dec 1;126(12):4702-4715. doi: 10.1172/JCI89031. Epub 2016 Nov 14.

Al-Garawi A, Carey VJ, Chhabra D, Mirzakhani H, Morrow J, Lasky-Su J, Qiu W, Laranjo N, Litonjua AA, Weiss ST. The Role of Vitamin D in the Transcriptional Program of Human Pregnancy. PLoS One. 2016 Oct 6;11(10):e0163832. doi: 10.1371/journal.pone.0163832. eCollection 2016.

Litonjua AA, Carey VJ, Laranjo N, Harshfield BJ, McElrath TF, O'Connor GT, Sandel M, Iverson RE Jr, Lee-Paritz A, Strunk RC, Bacharier LB, Macones GA, Zeiger RS, Schatz M, Hollis BW, Hornsby E, Hawrylowicz C, Wu AC, Weiss ST. Effect of Prenatal Supplementation With Vitamin D on Asthma or Recurrent Wheezing in Offspring by Age 3 Years: The VDAART Randomized Clinical Trial. JAMA. 2016 Jan 26;315(4):362-70. doi: 10.1001/jama.2015.18589.

Layout table for additonal information

Responsible Party:	Scott T. Weiss, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00920621
Other Study ID Numbers:	655 5U01HL091528-03 ( U.S. NIH Grant/Contract ) HL091528-01A1
First Submitted:	June 11, 2009
First Posted:	June 15, 2009
Results First Submitted:	February 28, 2017
Results First Posted:	July 14, 2017
Last Update Posted:	July 20, 2023