Vitamin D's effect on ovulation in women with PCOS
A Randomized Double-blind Controlled Trial on the Effect of Vitamin D on Ovulation Rate of Women With Polycystic Ovary Syndrome
This study tests if taking vitamin D can help women with PCOS have more regular ovulation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 3 sites (Hong Kong and 2 other locations) |
| Trial ID | NCT04650880 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of vitamin D supplementation on the ovulation rate in women diagnosed with polycystic ovary syndrome (PCOS). It is a randomized double-blind controlled trial where participants will receive either vitamin D or a placebo over a one-year period. The study aims to determine if vitamin D can improve ovulation rates either spontaneously or in conjunction with an oral ovulation induction agent. Participants will be monitored for reproductive, endocrine, and metabolic outcomes throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are premenopausal women aged 18-40 with irregular menstrual cycles and diagnosed with PCOS according to the Rotterdam criteria.
Not a fit: Patients currently using hormonal medications or those with conditions affecting vitamin D metabolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, non-invasive treatment option to improve ovulation rates in women with PCOS.
How similar studies have performed: While the approach of using vitamin D for ovulation in PCOS is promising, it remains relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hong Kong and 2 other locations
- Kwong Wah Hospital — Hong Kong, Hong Kong (Recruiting)
- Princess Margaret Hospital — Hong Kong, Hong Kong (Not_yet_recruiting)
- Queen Mary Hospital, University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.