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Effect of Vitamin D Supplementation on Testosterone Level in Women With Polycystic Ovary Syndrome

Effect of Vitamin D Supplementation on Testosterone Level in Women With Polycystic Ovary Syndrome: A Randomized, Double-blind, Placebo-controlled Trial

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06101147
Enrollment
66
Registered
2023-10-26
Start date
2023-09-21
Completion date
2024-07-30
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PCOS, Vitamin D

Keywords

PCOS, Vitamin D, Testosterone

Brief summary

The goal of this randomized, double blind, placebo-controlled clinical trial is to learn about, the effect of low dose vitamin D supplementation compares with placebo-controlled group on testosterone level in women with polycystic ovary syndrome. Half of Participants will receive vitamin D and metformin while other half placebo and metformin.

Detailed description

PCOS poses a significant challenge to women's health and quality of life. PCOS is a common heterogenous endocrine disorder in reproductive-aged women. PCOS is characterized by the presence of polycystic ovaries, menstrual dysfunction, infertility and biochemical (elevated androgens) and clinical (hirsutism and/or acne) hyperandrogenism. Hyperandrogenism and insulin resistance exacerbate one another in the development of PCOS, Research has suggested a potential link between Vitamin D deficiency and the prevalence and severity of PCOS. There is also evidence that Vitamin D has a direct effect on the ovaries and adrenal glands, which are the primary sites of androgen production in women. Vitamin D has been found to inhibit the synthesis of androgens in these glands, suggesting that it could potentially be used to manage hyperandrogenism in women with PCOS. Furthermore, studies have shown that Vitamin D supplementation can reduce insulin resistance in women with PCOS, which can subsequently lead to a decrease in the overproduction of androgens. may improves menstrual irregularities. In human ovarian tissue, vitamin D stimulation of oestrogen and progesterone production and lack of effect on testosterone production may be explained by the expression of the aromatase gene and augmentation of aromatase activity by vitamin D. Serum 25OH-D level has been shown to be negatively correlated with serum androgen levels DHEAS, testosterone and hirsutism. Assumption that vitamin D supplementation may also have a positive impact on serum testosterone levels. Metformin is prescribed for reducing IR in PCOS women. This is a double-blind, randomized placebo-controlled trial in PCOS women who are receiving Metformin therapy. The intervention group will receive Vitamin D Cholecalciferol (D3) 1000 I.U daily for 8 weeks, with the Metformin as prescribed by the physician whereas control group will receive placebo with Metformin during the study period. We will compare change of Total Testosterone, Vitamin D level, Fasting blood glucose, Hirsutism, Menstrual regularities and BMI, at the time of recruitment with after 8 weeks intervention in both the intervention and placebo controlled groups.

Interventions

DRUGVitamin D3

These patients will receive Vitamin D3 1000 I.U daily and the Metformin as prescribed by the physician for 8 weeks.

DRUGPlacebo Oral Tablet

These patients will receive placebo and the Metformin as prescribed by the physician for the same periods of study group

Sponsors

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* Diagnosed case of PCOS Age 18 years to 45 years

Exclusion criteria

* Pregnancy, lactating women Diagnosed case of diabetes mellitus, liver disease, heart disease, kidney stones and disease, Tuberculosis, hyperparathyroidism Patients receiving vitamin D, calcium supplementation within the last two months Known hypersensitivity to Vitamin D Patients unwilling to participate or unwilling to give written consent

Design outcomes

Primary

MeasureTime frameDescription
Total Testosterone1 yearThe estimated testosterone level, is 15-46 ng/dL for a reproductive aged normal menstrual cycles woman . The results demonstrate that there is a diurnal rhythm of testosterone secretion during in girls, with the highest levels in the morning 6 am-10 am .Biochemical hyperandrogenism (TT \>46 ng/dl)

Secondary

MeasureTime frameDescription
Fasting blood glucose1 yearImpaired fasting glucose (IFG) when FBG is between 5.6-6.9 mmol/L
Menstrual regularity1 year* Polymenorrheic (\<21 days), * Eumenorrheic (21 - 35 days), * Oligomenorrheic (36 days - 3 months) and * Amenorrheic (\>3 months)
Hirsutism1 yearmFG score of ≥6
Vitamin D1 YearA blood level of less than 20 ng/ml is considered deficiency, insufficiency is 21- 29 ng/ml, and sufficiency is 30 ng/ml or higher.
BMI1 YearStatus BMI Underweight 15-19.9 Normal weight 20-24.9 Overweight 25-29.9 Class I Obesity 30-34.9 Class II Obesity 35-39.9 Class III Obesity ≥ 40

Countries

Bangladesh

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026