The Investigation of Vitamin D and Menstrual Cycles Trial, the inVitD Trial: A Phase II Randomized Trial
Vitamin D Deficiency
About this trial
This is an interventional basic science trial for Vitamin D Deficiency focused on measuring reproductive, Health, Female, Hormones, period
Eligibility Criteria
- 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
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.
Sites / Locations
- NIEHS Clinical Research Unit (CRU)Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
1/High Dose Vitamin D
2/Placebo
Deficient women will be assigned to the Endocrine Society recommendation for deficiency, 50,000 IU/week.
Sufficient women who will receive placebo instead of Vitamin D supplementation.