NCT04650880 Effect of Vitamin D on Ovulation Rate in Women With Polycystic Ovary Syndrome
| NCT ID | NCT04650880 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Hong Kong |
| Condition | Polycystic Ovary Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2021-01-26 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 220 participants in total. It began in 2021-01-26 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Premenopausal * Aged 18-40 years * Irregular long menstrual cycles (\>35 days) * PCOS according to the Rotterdam criteria * Agree for transvaginal ultrasound Exclusion Criteria: * 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.
Frequently Asked Questions
Who can join the NCT04650880 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Polycystic Ovary Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04650880 currently recruiting?
Yes, NCT04650880 is actively recruiting participants. Visit ClinicalTrials.gov or contact The University of Hong Kong to inquire about joining.
Where is the NCT04650880 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong, Hong Kong, Hong Kong, Hong Kong, Hong Kong.
Who is sponsoring the NCT04650880 clinical trial?
NCT04650880 is sponsored by The University of Hong Kong. The trial plans to enroll 220 participants.