Clinical trial NCT06101147: Effect of Vitamin D Supplementation on Testosterone Level in Women With Polycystic Ovary Syndrome
Official title: Effect of Vitamin D Supplementation on Testosterone Level in Women With Polycystic Ovary Syndrome: A Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: PCOS
Vitamin D
Keywords: PCOS, Vitamin D, Testosterone
Lead sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Testosterone
timeFrame: 1 year
Secondary outcomes:
measure: Fasting blood glucose
timeFrame: 1 year
measure: Menstrual regularity
timeFrame: 1 year
measure: Hirsutism
timeFrame: 1 year
measure: Vitamin D
timeFrame: 1 Year
measure: BMI
timeFrame: 1 Year
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: BSMMU
Study officials:
affiliation: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
name: Nilufar Yasmin, MD
role: PRINCIPAL_INVESTIGATOR
References: