NCT04650880

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The hypothesis is that vitamin D supplementation results in significant improvement in the ovulation rate of women with PCOS either spontaneously or with oral ovulation induction agent. Anovulatory women with PCOS diagnosed by the Rotterdam criteria will be recruited. Participants will be randomized to the (1) vitamin D group or (2) placebo group. Those in the vitamin D group will take vitamin D 50,000 IU/ week for 4 weeks, followed by 50,000IU once every 2 weeks for 52 weeks, whereas those in the placebo group will take placebo tablets with the same external appearance. Those who remain anovulatory after 6 months will be treated with a 6-month course of letrozole (2.5mg to 7.5mg for 5 days per cycle titrated according to response) for ovulation induction. The primary outcome is the ovulation rate and will be compared between the 2 groups.

Conditions

• Polycystic Ovary Syndrome
• Anovulation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin D	Vitamin D supplementation
OTHER	Placebo	Placebo tablets with the same external appearance

Timeline

• Start date: 2021-01-26
• Primary completion: 2024-12-31
• Completion: 2026-12-31
• First posted: 2020-12-03
• Last updated: 2024-05-14

Locations

3 sites across 1 country: Hong Kong