About this trial
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
This trial does not accept healthy volunteersQualifiers
Premenopausal
Aged 18-40 years
Irregular long menstrual cycles (>35 days)
PCOS according to the Rotterdam criteria
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Vitamin D
Dietary supplementVitamin D supplementation
Placebo
Other interventionPlacebo tablets with the same external appearance
Treatment groups
Trial outcomes
Primary outcomes
Ovulation rate
Serum progesterone
Secondary outcomes
Change in serum 25(OH)D level
Serum 25(OH)D
Pregnancy rate
Positive urine or serum hCG test
Live birth rate
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
Change in serum anti-Mullerian hormone level
serum AMH level
Sponsors and contacts
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The University of Hong Kong
Lead sponsor
Kwong Wah Hospital
Collaborator
Princess Margaret Hospital, Hong Kong
Collaborator
Pamela Youde Nethersole Eastern Hospital
Collaborator
The Queen Elizabeth Hospital
Collaborator