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NCT Number: NCT04650880

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kwong Wah Hospital, Hong Kong

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin D

Dietary Supplement

Vitamin D supplementation

Placebo

Other

Placebo tablets with the same external appearance

Primary outcomes

  1. Ovulation rate

    Time frame: 12 months

    Serum progesterone

Secondary outcomes

  1. Change in serum 25(OH)D level

    Time frame: 12 months

    Serum 25(OH)D

  2. Pregnancy rate

    Time frame: 12 months

    Positive urine or serum hCG test

  3. Live birth rate

    Time frame: 12 months

    Delivery of a baby after 22 completed weeks of gestational age, or with birth weight of 500 grams if the gestation age is unknown, which shows evidence of life

  4. Change in serum anti-Mullerian hormone level

    Time frame: 12 months

    serum AMH level

  5. Change in antral follicle count

    Time frame: 12 months

    Antral follicle count measured by transvaginal/ transrectal ultrasound

  6. Androgen indices

    Time frame: 12 months

    serum androgen and androstenedione levels, SHBG

  7. Body mass index

    Time frame: 12 months

    Height in cm, weight in kg, to calculate the body mass index (kg/m^2)

  8. Change in waist and hip circumference

    Time frame: 12 months

    waist and hip circumference in cm

  9. Rate of diabetes mellitus/ impaired glucose intolerance

    Time frame: 12 months

    Measured by fasting and 2 hour glucose (post 75g OGTT)

  10. Change in systolic and diastolic blood pressure

    Time frame: 12 months

    Blood pressure

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Kwong Wah Hospital
  • Pamela Youde Nethersole Eastern Hospital
  • Princess Margaret Hospital, Hong Kong
  • The Queen Elizabeth Hospital

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Dec 3, 2020
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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