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

Last updated: May 13, 2024
Sponsor: The University of Hong Kong
Overall Status: Active - Recruiting

Phase

N/A

Condition

Infertility

Female Hormonal Deficiencies/abnormalities

Polycystic Ovarian Syndrome

Treatment

Vitamin D

Placebo

Clinical Study ID

NCT04650880
UW20-004
  • Ages 18-40
  • Female

Study 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

Inclusion Criteria:

  • Premenopausal

  • Aged 18-40 years

  • Irregular long menstrual cycles (>35 days)

  • PCOS according to the Rotterdam criteria

  • Agree for transvaginal ultrasound

Exclusion

Exclusion Criteria:

  • Use of hormonal medication (including contraception) within 3 months prior to studyinclusion, except the use of a progestogen to induce withdrawal bleeding every 3months

  • History of any medical condition or medications that may predispose to vitamin Dsensitivity, altered vitamin D metabolism and/ or hypercalcemia, including activetuberculosis or current therapy for tuberculosis, sarcoidosis, history of renal/ureteral stones, parathyroid disease, renal or liver failure or current use ofanti-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.

Study Design

Total Participants: 220
Treatment Group(s): 2
Primary Treatment: Vitamin D
Phase:
Study Start date:
January 26, 2021
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Kwong Wah Hospital

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • Princess Margaret Hospital

    Hong Kong,
    Hong Kong

    Site Not Available

  • Queen Mary Hospital, University of Hong Kong

    Hong Kong,
    Hong Kong

    Active - Recruiting

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