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

NCT06101147 | Completed Phase 2 DMC

• 1 other identifier: BSMMU/2023/11021
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

PCOS; Vitamin D

Keywords

PCOS, Vitamin D, Testosterone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Fasting blood glucose

  1 year

• Menstrual regularity

  1 year

• Hirsutism

  1 year

• Vitamin D

  1 Year

• BMI

  1 Year

Study Arms (2)

Vitamin D group

EXPERIMENTAL

Drug: Vitamin D3

Placebo group

PLACEBO COMPARATOR

Drug: Placebo Oral Tablet

Interventions

Vitamin D3 DRUG

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

Vitamin D group

Placebo Oral Tablet DRUG

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

Placebo group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed case of PCOS
• Age 18 years to 45 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

BSMMU

Dhaka, 1000, Bangladesh

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Nilufar Yasmin, MD

  Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident, MD

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: October 26, 2023
• Study Start: September 21, 2023
• Primary Completion: April 30, 2024
• Study Completion: July 30, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share

Locations

BA (1)