Menu
Recruiting NCT04650880

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

No phase Interventional Polycystic Ovary Syndrome Anovulation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vitamin D, Placebo.
Who it may be relevant to
Registry conditions: Polycystic Ovary Syndrome, Anovulation. Basic parameters: 18 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized Double-blind Controlled Trial on the Effect of Vitamin D on Ovulation Rate of Women With Polycystic Ovary Syndrome

Overview

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.

Interventions

  • Dietary supplement Vitamin D
    Vitamin D supplementation
  • Other Placebo
    Placebo tablets with the same external appearance

Primary outcome measures

  • Ovulation rate [Time frame: 12 months]
Secondary outcome measures (10)
  • Change in serum 25(OH)D level [Time frame: 12 months]
  • Pregnancy rate [Time frame: 12 months]
  • Live birth rate [Time frame: 12 months]
  • Change in serum anti-Mullerian hormone level [Time frame: 12 months]
  • Change in antral follicle count [Time frame: 12 months]
  • Androgen indices [Time frame: 12 months]
  • Body mass index [Time frame: 12 months]
  • Change in waist and hip circumference [Time frame: 12 months]
  • Rate of diabetes mellitus/ impaired glucose intolerance [Time frame: 12 months]
  • Change in systolic and diastolic blood pressure [Time frame: 12 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Hong Kong · 3 centers
  • Kwong Wah Hospital — Hong Kong
  • Princess Margaret Hospital — Hong Kong
  • Queen Mary Hospital, University of Hong Kong — Hong Kong

Publications

  • Ko JKY, Yung SSF, Lai SF, Wan RSF, Wong CKY, Wong K, Cheung CL, Ng EHY, Li RHW. Effect of vitamin D in addition to letrozole on the ovulation rate of women with polycystic ovary syndrome: protocol of a multicentre randomised double-blind controlled trial. BMJ Open. 2024 Apr 29;14(4):e070801. doi: 10.1136/bmjopen-2022-070801. PMID 38684265

Identifiers

NCT: NCT04650880 · UW20-004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗