Effect of Vitamin D on Ovulation Rate in Women With Polycystic Ovary Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-26

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Vitamin D and Pregnancy Outcome in PCOS Patients

NCT04082650

Polycystic Ovary Syndrome in Vitro Fertilization

COMPLETED NA

Vitamin D and Endometrial Receptivity in Infertile Women

NCT04721899

Infertility

RECRUITING

Effect of Vitamin D Supplementation in Live Birth Rate of in Vitro Fertilization Outcome

NCT04547530

Infertility

UNKNOWN PHASE4

Evaluation of the Clinical and Psychological Impact of Vitamin D Replacement in Adolescent Females at Risk for Polycystic Ovarian Syndrome (PCOS)

NCT04355572

Polycystic Ovarian Syndrome in Adolescent Females Vitamin D Deficiency

RECRUITING NA

Vitamin D Increases Serum Levels of the Soluble Receptor for Advanced Glycation End Products in Women With PCOS

NCT03644212

Polycystic Ovary Syndrome Vitamin D Deficiency

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Polycystic Ovary Syndrome Anovulation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vitamin D

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.

Group Type ACTIVE_COMPARATOR

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

Vitamin D supplementation

Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo tablets with the same external appearance

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vitamin D

Vitamin D supplementation

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo tablets with the same external appearance

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No