Clinical trial NCT04650880: Effect of Vitamin D on Ovulation Rate in Women With Polycystic Ovary Syndrome
Official title: A Randomized Double-blind Controlled Trial on the Effect of Vitamin D on Ovulation Rate of Women With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Polycystic Ovary Syndrome
Anovulation
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Kwong Wah Hospital
name: Princess Margaret Hospital, Hong Kong
name: Pamela Youde Nethersole Eastern Hospital
name: The Queen Elizabeth Hospital
First posted: 2020-12-03
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ovulation rate
timeFrame: 12 months
Secondary outcomes:
measure: Change in serum 25(OH)D level
timeFrame: 12 months
measure: Pregnancy rate
timeFrame: 12 months
measure: Live birth rate
timeFrame: 12 months
measure: Change in serum anti-Mullerian hormone level
timeFrame: 12 months
measure: Change in antral follicle count
timeFrame: 12 months
measure: Androgen indices
timeFrame: 12 months
measure: Body mass index
timeFrame: 12 months
measure: Change in waist and hip circumference
timeFrame: 12 months
measure: Rate of diabetes mellitus/ impaired glucose intolerance
timeFrame: 12 months
measure: Change in systolic and diastolic blood pressure
timeFrame: 12 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Kwong Wah Hospital
city: Hong Kong
country: Hong Kong
facility: Princess Margaret Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital, University of Hong Kong
Study officials:
References: