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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
220
Kwong Wah Hospital
Hong Kong, Hong Kong
RECRUITINGPrincess Margaret Hospital
Hong Kong, Hong Kong
NOT_YET_RECRUITINGQueen Mary Hospital, University of Hong Kong
Hong Kong, Hong Kong
RECRUITINGOvulation rate
Serum progesterone
Time frame: 12 months
Change in serum 25(OH)D level
Serum 25(OH)D
Time frame: 12 months
Pregnancy rate
Positive urine or serum hCG test
Time frame: 12 months
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
Time frame: 12 months
Change in serum anti-Mullerian hormone level
serum AMH level
Time frame: 12 months
Change in antral follicle count
Antral follicle count measured by transvaginal/ transrectal ultrasound
Time frame: 12 months
Androgen indices
serum androgen and androstenedione levels, SHBG
Time frame: 12 months
Body mass index
Height in cm, weight in kg, to calculate the body mass index (kg/m\^2)
Time frame: 12 months
Change in waist and hip circumference
waist and hip circumference in cm
Time frame: 12 months
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Rate of diabetes mellitus/ impaired glucose intolerance
Measured by fasting and 2 hour glucose (post 75g OGTT)
Time frame: 12 months
Change in systolic and diastolic blood pressure
Blood pressure
Time frame: 12 months