Vitamin D for PCOS

Overseen By Alla Vash-Margita, MD

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Hyperandrogenism, Chronic renal diseases, others

Compensation: Varies

Number of Visits: 5

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether vitamin D supplements can help manage symptoms in individuals with PCOS, a condition affecting hormone levels, who have low vitamin D. Participants are randomly assigned to take either a vitamin D supplement or a placebo (a dummy treatment) for six months, without knowing which one they receive. The researchers aim to determine if vitamin D makes a difference compared to a placebo. The study seeks girls and young women aged 13 to 21 with PCOS and low vitamin D levels. As an unphased trial, it offers participants the chance to contribute to important research that could enhance understanding and management of PCOS symptoms.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that Vitamin D is generally safe for use. Research on its effects on polycystic ovary syndrome (PCOS) has found that taking Vitamin D can help with symptoms like irregular periods and insulin issues. These studies reported no serious side effects.

Vitamin D is a common supplement used safely by many. However, following the recommended dose and consulting a healthcare provider if concerns arise is important. In this trial, participants will take a specific dose daily for six months, which studies have found manageable for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Vitamin D for PCOS because it offers a potential new way to manage this condition that differs from standard treatments like hormonal birth control and insulin-sensitizing drugs. Unlike these conventional options, Vitamin D is a natural supplement that may help regulate menstrual cycles and improve insulin resistance without the side effects often associated with hormones or medications. Additionally, Vitamin D is easy to administer with a daily tablet, making it a simple and non-invasive option for patients. This approach could offer a more holistic and accessible alternative for managing PCOS symptoms.

What evidence suggests that Vitamin D might be an effective treatment for PCOS?

In this trial, participants will join one of two groups: one will receive Vitamin D supplements, while the other will receive a placebo. Research has shown that Vitamin D can benefit women with polycystic ovary syndrome (PCOS) in several ways. Studies have found that it can regulate menstrual cycles and aid in egg development. Vitamin D also lowers testosterone levels and reduces insulin resistance, common issues in PCOS. Some research suggests it can enhance fat metabolism. Overall, Vitamin D appears promising for improving several health issues related to PCOS. ^{3 5 6 7 8}

Who Is on the Research Team?

Alla Vash-Margita, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

Adolescent females aged 13-21 with PCOS and low vitamin D levels (6-29 ng/mL) are eligible for this trial. They must meet modified Rotterdam criteria for PCOS, which helps diagnose the condition based on symptoms like irregular periods or excess male hormone levels.

Inclusion Criteria

I am a female aged 13-21 with PCOS and low vitamin D levels.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Randomization and Treatment

Participants are randomized to receive either vitamin D supplement or placebo and followed for 6 months with repeat laboratory testing and depression assessments

6 months

3 visits (in-person) at randomization, 3 months, and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, and those with low vitamin D levels are offered treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Vitamin D

Trial Overview The study is testing if taking Vitamin D supplements (4000IU daily) affects clinical and psychological aspects of PCOS compared to a placebo. It's a double-blind trial, meaning neither participants nor researchers know who gets Vitamin D or the placebo until it ends.

How Is the Trial Designed?

Group I: Vitamin D Supplement Experimental Treatment 1 Intervention

Patients will take vitamin D tablet with 4,000IU daily for 6 months.

Group II: Placebo Placebo Group 1 Intervention

Patients will take placebo for 6 months

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10328709/

Vitamin D and polycystic ovary syndrome (PCOS): a review Vitamin D supplementation improved menstrual periods, increased folliculogenesis, and decreased blood testosterone levels in PCOS patients.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7086222/

Effect of vitamin D supplementation on polycystic ovary ... Vitamin D supplementation reduced insulin resistance and hyperandrogenism, as well improving the lipid metabolism of patients with PCOS to an extent.

3. ovarianresearch.biomedcentral.com ovarianresearch.biomedcentral.com/articles/10.1186/s13048-024-01473-6

Effects of vitamin D supplementation on metabolic parameters ... Vitamin D supplementation had beneficial effects on metabolic parameters in PCOS women, especially in women with obesity or insulin resistance.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1472648324000981

Effect of vitamin D on pregnancy in women with polycystic ... Vitamin D supplementation can improve the pregnancy rate of ovulation induction, and improve the high LH and testosterone concentrations in women with PCOS who ...

5. apm.amegroups.org apm.amegroups.org/article/view/61538/html

Vitamin D improves levels of hormonal, oxidative stress and ... The current meta-analysis demonstrates that vitamin D supplementation in patients with PCOS resulted in an improvement in the levels of TT, hs-CRP, TAC, and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11990587/

Effects of Vitamin D3 Treatment on Polycystic Ovary Symptoms Our results suggest that vitamin D3 treatment could function as either a standalone or an adjunctive therapy in the management of PCOS.

7. nature.com nature.com/articles/s41598-025-14728-z

Supervised model based polycystic ovarian syndrome ... Vitamin D3 is a highly relevant feature, where low levels may relate to PCOS. Follicle counts and AMH do correlate with ultrasound based ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02460380

The Effects of Vitamin D on Angiogenic Factors in Women ... Therefore, the investigators hypothesize that vitamin D treatment of PCOS women will result in a decrease of serum TGF-β1 levels and/or VEGF levels concomitant ...