BridgeMD
New treatment option for Polycystic Ovary Syndrome
Official title Effect of Vitamin D on Ovulation Rate in Women With Polycystic Ovary Syndrome
ClinicalTrials.gov ID: NCT04650880
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40, women only
You may be able to join if
- Premenopausal
- Aged 18-40 years
- Irregular long menstrual cycles (\>35 days)
- PCOS according to the Rotterdam criteria
- Agree for transvaginal ultrasound
You likely can't join if
- Use of hormonal medication (including contraception) within 3 months prior to study inclusion, except the use of a progestogen to induce withdrawal...
- History of any medical condition or medications that may predispose to vitamin D sensitivity, altered vitamin D metabolism and/ or hypercalcemia...
- 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
See the full eligibility criteria
- Premenopausal
- Aged 18-40 years
- Irregular long menstrual cycles (\>35 days)
- PCOS according to the Rotterdam criteria
- Agree for transvaginal ultrasound
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong, Hong Kong
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong, Hong Kong. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.