Effect of Vitamin D on Ovulation Rate in Women With Polycystic Ovary Syndrome
- Conditions
- Polycystic Ovary SyndromeAnovulation
- Registration Number
- NCT04650880
- Lead Sponsor
- The University of Hong Kong
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 220
- Premenopausal
- Aged 18-40 years
- Irregular long menstrual cycles (>35 days)
- PCOS according to the Rotterdam criteria
- Agree for transvaginal ultrasound
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Ovulation rate 12 months Serum progesterone
- Secondary Outcome Measures
Name Time Method Change in antral follicle count 12 months Antral follicle count measured by transvaginal/ transrectal ultrasound
Pregnancy rate 12 months Positive urine or serum hCG test
Live birth rate 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
Androgen indices 12 months serum androgen and androstenedione levels, SHBG
Body mass index 12 months Height in cm, weight in kg, to calculate the body mass index (kg/m\^2)
Change in systolic and diastolic blood pressure 12 months Blood pressure
Change in serum 25(OH)D level 12 months Serum 25(OH)D
Change in waist and hip circumference 12 months waist and hip circumference in cm
Change in serum anti-Mullerian hormone level 12 months serum AMH level
Rate of diabetes mellitus/ impaired glucose intolerance 12 months Measured by fasting and 2 hour glucose (post 75g OGTT)
Trial Locations
- Locations (3)
Kwong Wah Hospital
🇭🇰Hong Kong, Hong Kong
Princess Margaret Hospital
🇭🇰Hong Kong, Hong Kong
Queen Mary Hospital, University of Hong Kong
🇭🇰Hong Kong, Hong Kong
Kwong Wah Hospital🇭🇰Hong Kong, Hong KongShui Fan Lai, MBBS, MRCOGContact+852 35175183lsf087@ha.org.hk