Effect of Vitamin D on Ovulation Rate in Women With Polycystic Ovary Syndrome

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    220
  • sponsor
    The University of Hong Kong
Updated on 9 June 2021

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.

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.

Details
Condition OVARIAN CYST, Ovarian disorder, Anovulation, Ovulation, Polycystic Ovary Syndrome, Polycystic Ovarian Syndrome, pcos, polycystic ovary disease, anovulatory
Treatment Placebo, Vitamin D
Clinical Study IdentifierNCT04650880
SponsorThe University of Hong Kong
Last Modified on9 June 2021

Eligibility

Yes No Not Sure

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
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