The Investigation of Vitamin D and Menstrual Cycles Trial, the inVitD Trial: A Phase II Randomized Trial
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ClinicalTrials.gov Identifier: NCT05050916 |
Recruitment Status :
Active, not recruiting
First Posted : September 21, 2021
Last Update Posted : March 22, 2024
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Background:
About 1.5 million U.S. women of reproductive age are estimated to be infertile. Many more have difficulty getting pregnant. Menstrual cycles are an indicator of a woman s general health. Menstrual cycle changes may predict difficulties in getting pregnant. Researchers want to see what role vitamin D may play in menstrual cycle health.
Objective:
To examine the effect of vitamin D supplementation on the hormones that come from the brain and the ovary during a menstrual cycle.
Eligibility:
Women aged 19-40 who have spontaneous menstrual cycles (are not taking any hormones) less than 50 days in length.
Design:
Participants will fill out a screening survey about their demographics and health history. It will take 5-10 minutes to complete.
Participants will have 3 study visits. Participants who are deficient and move to Phase 2 will receive a 5000 IU dose of vitamin D supplements. Participants who are sufficient will receive placebo. If they are vitamin D deficient, they will not get the placebo. They will take the capsules by mouth, once per week, for 3 menstrual cycles (or about 90 days).
Participants will have physical exams. Their height, weight, body fat percentage, blood pressure, and waist-hip ratio will be measured. They will give blood samples. They will have self-administered vaginal and oral swabs.
Participants will keep a daily menstrual diary. They will do daily home ovulation testing. They will collect urine at home. Some women may collect menstrual blood at home.
Participants will fill out an online survey. It will ask about their health, diet, and physical activity; birth control use; pregnancy history; menstrual cycle; smoking and drinking habits; education; and occupation. It will take 20-30 minutes to complete.
Participation will last for four menstrual cycles (about 4 months).
Condition or disease | Intervention/treatment | Phase |
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Vitamin D Deficiency | Dietary Supplement: Vitamin D | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 57 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Basic Science |
Official Title: | The Investigation of Vitamin D and Menstrual Cycles Trial: A Phase II Clinical Trial |
Actual Study Start Date : | March 17, 2023 |
Estimated Primary Completion Date : | November 30, 2024 |
Estimated Study Completion Date : | November 30, 2024 |
Arm | Intervention/treatment |
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Experimental: 1/High Dose Vitamin D
Deficient women will be assigned to the Endocrine Society recommendation for deficiency, 50,000 IU/week.
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Dietary Supplement: Vitamin D
This is a Phase II randomized, dose-ranging clinical trial including 1) a within-woman comparison of hormones pre-and post-supplementation and 2) a comparison across women on a Vitamin D and a placebo. After recruitment, there will be two phases: Phase 1 will follow all women for one menstrual cycle prior to supplementation; blood will be assayed for 25OHD. Phase 2 includes only: 1) women with less than 20 ng/ml 25OHD ("deficient") OR 2) a sample of women with >20 ng/ml 25OHD ("sufficient") as the placebo group. During Phase 2, deficient women will be assigned to receive a blinded dose of 50,000 IU of vitamin D supplementation per week and followed for three more menstrual cycles. Hormone levels will be compared between the pre-and post-supplementation cycles as the primary analysis. The primary aim will test: if mid-luteal progesterone, rate of estrogen rise and pre-ovulatory LH are higher in vitamin D supplemented cycles. |
Placebo Comparator: 2/Placebo
Sufficient women who will receive placebo instead of Vitamin D supplementation.
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Dietary Supplement: Vitamin D
This is a Phase II randomized, dose-ranging clinical trial including 1) a within-woman comparison of hormones pre-and post-supplementation and 2) a comparison across women on a Vitamin D and a placebo. After recruitment, there will be two phases: Phase 1 will follow all women for one menstrual cycle prior to supplementation; blood will be assayed for 25OHD. Phase 2 includes only: 1) women with less than 20 ng/ml 25OHD ("deficient") OR 2) a sample of women with >20 ng/ml 25OHD ("sufficient") as the placebo group. During Phase 2, deficient women will be assigned to receive a blinded dose of 50,000 IU of vitamin D supplementation per week and followed for three more menstrual cycles. Hormone levels will be compared between the pre-and post-supplementation cycles as the primary analysis. The primary aim will test: if mid-luteal progesterone, rate of estrogen rise and pre-ovulatory LH are higher in vitamin D supplemented cycles. |
- To examine the effect of vitamin D supplementation on hypothalamic-pituitary-ovarian axis hormones. [ Time Frame: 60 months ]We will evaluate the extent to which vitamin D supplementation: 1) Increases urinary mid-luteal progesterone (an indicator of healthy, fertile follicle development) 2) Increases the rate of rise in urinary follicular phase estrogen (an indicator of follicular development) 3) Increases urinary pre-ovulatory LH (an indicator of healthy ovarian-hypothalamic interaction)
- To quantify the increase in 25OHD and the fraction who achieve a level of 40 ng/ml after 1.5 and 3 months of supplementation, in response to 50,000 IU/week of vitamin D. [ Time Frame: 60 months ]25OHD
- To investigate the effect of vitamin D supplementation on the microbiome [ Time Frame: 60 months ]Untargeted microbiome profiling
- To investigate the effect of vitamin D supplementation on endometrial stromal cell function. [ Time Frame: 60 months ]Endometrial stromal cells isolated from menstrual effluent.
- To examine the change in whole blood metals levels in response to vitamin D supplementation. [ Time Frame: 60 months ]Whole blood lead
- Determine the impact of Vitamin D supplementation in reproductive-aged women by assaying the metabolome before and after vitamin D supplementation. [ Time Frame: 60 months ]Untargeted metabolomics
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 19 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
- INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Having natural, spontaneous menstrual cycles (no hormonal therapy) less than 50 days in length.
- Aged 19-40 years
- Ability to take a vitamin D capsule and willing to adhere to the weekly regimen
- If sexually active, use of a non-hormonal contraceptive method.
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
- No menstrual period in the last 50 days, or, a typical menstrual cycle length <16 or >49 days.
- Use of a vitamin D supplement for more than one month and on more than 15 days out of each month. Volunteers will be asked to check their supplement label for vitamin D content.
- Unwilling to abstain from taking non-study vitamin D supplements during the study or if already taking a medically-advised vitamin D supplement.
- Use of a calcium supplement (including certain antacids) and unwilling to abstain from taking a calcium supplement during the study.
- Known polycystic ovarian syndrome
- Depo-provera use in the previous 12 months
- Current use of any hormones, including birth control
- Current use of a hormonal intrauterine device (IUD)
- Current pregnancy or lactation, trying to become pregnant, or planning to try in the next four menstrual cycles or 5 months.
- History of seizure disorders
- Celiac disease
- Crohn s Disease
- Body mass index >35
- Aged <19 or > 40 years
- Presence of known contraindications for vitamin D supplementation, history of any of the following: calcium disorder or hypercalcemia, tuberculosis or granulomatous disease, metastatic bone disease, sarcoidosis, Williams syndrome, kidney disease (kidney stones, renal failure or dialysis, lupus nephritis)
- Known liver disease (cirrhosis)
- History of cancer other than skin cancer.
- History of anorexia nervosa, bulimia or an eating disorder
- Use within the past 60 days, of exogenous hormones
- Type 1 or Type 2 diabetes
- Known heart disease
- Gastric bypass surgery
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Unwilling or unable to complete study activities, e.g. collect daily urine specimens, have blood drawn, complete daily diaries, attend in person study visits
25. Non-English speaking
- Due to the complexity of daily/weekly diaries, testing and procedurerequirements, all consents, instructions and questionnaires are provided in English. Therefore, all participants must be able to able to read and speak English.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05050916
United States, Michigan | |
Henry Ford Health System | |
Detroit, Michigan, United States, 48187 | |
United States, North Carolina | |
NIEHS Clinical Research Unit (CRU) | |
Research Triangle Park, North Carolina, United States, 27709 |
Principal Investigator: | Anne Marie Z Jukic, Ph.D. | National Institute of Environmental Health Sciences (NIEHS) |
Responsible Party: | National Institute of Environmental Health Sciences (NIEHS) |
ClinicalTrials.gov Identifier: | NCT05050916 |
Other Study ID Numbers: |
10000476 000476-E |
First Posted: | September 21, 2021 Key Record Dates |
Last Update Posted: | March 22, 2024 |
Last Verified: | March 20, 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
reproductive Health Female Hormones period |
Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders |
Vitamin D Vitamins Micronutrients Physiological Effects of Drugs Bone Density Conservation Agents |