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

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.

Study Overview

• Status: Recruiting
• Conditions: PCOS; Vitamin D
• Intervention / Treatment: Drug: Vitamin D3; Drug: Placebo Oral Tablet

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.

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Nilufar Yasmin, MD; Phone Number: 01935444975; Email: nilufaryasmin975@gmail.com

Study Locations

• Bangladesh
  • Dhaka, Bangladesh, 1000
    • Recruiting
    • BSMMU
    • Contact: Dr.Swapan Kumar Tapader; Phone Number: 88029661064; Email: registrar@bsmmu.edu.bd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group	Drug: Placebo Oral Tablet; These patients will receive placebo and the Metformin as prescribed by the physician for the same periods of study group
Experimental: Vitamin D group	Drug: Vitamin D3; These patients will receive Vitamin D3 1000 I.U daily and the Metformin as prescribed by the physician for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Testosterone	The 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)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting blood glucose	Impaired fasting glucose (IFG) when FBG is between 5.6-6.9 mmol/L	1 year
Menstrual regularity	Polymenorrheic (<21 days),; Eumenorrheic (21 - 35 days),; Oligomenorrheic (36 days - 3 months) and; Amenorrheic (>3 months)	1 year
Hirsutism	mFG score of ≥6	1 year
Vitamin D	A 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.	1 Year
BMI	Status 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	1 Year

Collaborators and Investigators

• Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Investigators: Principal Investigator: Nilufar Yasmin, MD, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: October 20, 2023
• First Submitted That Met QC Criteria: October 20, 2023
• First Posted (Actual): October 26, 2023

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 29, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: PCOS, Vitamin D, Testosterone
• Additional Relevant MeSH Terms: Neoplasms; Endocrine System Diseases; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Polycystic Ovary Syndrome; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: BSMMU/2023/11021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No