RecruitingNot ApplicableNCT04650880
Effect of Vitamin D on Ovulation Rate in Women With Polycystic Ovary Syndrome
A Randomized Double-blind Controlled Trial on the Effect of Vitamin D on Ovulation Rate of Women With Polycystic Ovary Syndrome
Sponsor
The University of Hong Kong
Enrollment
220 participants
Start Date
Jan 26, 2021
Study Type
INTERVENTIONAL
Conditions
Summary
This is a randomized double-blind controlled trial on the effect of vitamin D supplementation to assess the ovulation rate of women with polycystic ovary syndrome (PCOS) and other reproductive, endocrine and metabolic outcomes after one year of treatment.
Eligibility
Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years
Inclusion Criteria5
- Premenopausal
- Aged 18-40 years
- Irregular long menstrual cycles (\>35 days)
- PCOS according to the Rotterdam criteria
- Agree for transvaginal ultrasound
Exclusion Criteria8
- Use of hormonal medication (including contraception) within 3 months prior to study inclusion, except the use of a progestogen to induce withdrawal bleeding every 3 months
- History of any medical condition or medications that may predispose to vitamin D sensitivity, altered vitamin D metabolism and/ or hypercalcemia, including active tuberculosis or current therapy for tuberculosis, sarcoidosis, history of renal/ ureteral stones, parathyroid disease, renal or liver failure or current use of anti-convulsants
- Use of insulin-sensitizing drugs, lipid lowering drugs or anti-hypertensive
- Anticipated to use the above medications in the coming one year
- Known type 2 diabetes mellitus
- Refusal to join the study
- Abnormal blood calcium level
- For those on supplements, we asked them to stop their own supplements.
Interventions
DIETARY_SUPPLEMENTVitamin D
Vitamin D supplementation
OTHERPlacebo
Placebo tablets with the same external appearance
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04650880
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