Vitamin D
Dietary SupplementVitamin D supplementation
NCT Number: NCT04650880
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.
Interested in participating?
Request Info18 year–40 year
Female
Interventional
Not applicable
Kwong Wah Hospital, Hong Kong
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
For those on supplements, we asked them to stop their own supplements.
Vitamin D supplementation
Placebo tablets with the same external appearance
Time frame: 12 months
Serum progesterone
Time frame: 12 months
Serum 25(OH)D
Time frame: 12 months
Positive urine or serum hCG test
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
Time frame: 12 months
serum AMH level
Time frame: 12 months
Antral follicle count measured by transvaginal/ transrectal ultrasound
Time frame: 12 months
serum androgen and androstenedione levels, SHBG
Time frame: 12 months
Height in cm, weight in kg, to calculate the body mass index (kg/m^2)
Time frame: 12 months
waist and hip circumference in cm
Time frame: 12 months
Measured by fasting and 2 hour glucose (post 75g OGTT)
Time frame: 12 months
Blood pressure
The University of Hong Kong
Other
A Randomized Double-blind Controlled Trial on the Effect of Vitamin D on Ovulation Rate of Women With Polycystic Ovary Syndrome
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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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