An interventional study of Vitamin D and Placebo in Polycystic Ovary Syndrome and Anovulation, sponsored by The University of Hong Kong. Recruiting at 3 sites in Hong Kong. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-05-14.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Treatment
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.
956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.
This study's planned enrollment of 220 is above the median of 70 across 697 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →The University of Hong Kong is the lead sponsor of 1,292 studies on the registry; 348 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
For those on supplements, we asked them to stop their own supplements.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vitamin D 50,000 IU/ week for 4 weeks, followed by 50,000 IU once every 2 weeks for 52 weeks 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.
Dietary Supplement: Vitamin D
Placebo tablets with same external appearance for 52 weeks 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.
Other: Placebo
Vitamin D supplementation
Placebo tablets with the same external appearance
Ovulation 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
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
Plan to share: Yes — all IPD that underlie results in a publication
Time frame: starting 6 months after publication
Access criteria: review by investigators
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Vitamin D