Effect of Vitamin D on Ovulation Rate in Women With Polycystic Ovary Syndrome
Recruiting · NCT04650880 · Interventional (participants receive a specific treatment) · Lead sponsor: The University of Hong Kong
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboVitamin D
What this trial is about
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.
Who can take part
Age range
18 Years to 40 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Premenopausal
- Aged 18-40 years
- Irregular long menstrual cycles (\>35 days)
- PCOS according to the Rotterdam criteria
- Agree for transvaginal ultrasound
Exclusion criteria
- 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.
Where it is running
3 locations listed.
- 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