Vitamin D Supplementation in PCOS Patients

Phase 4

Completed

• Conditions: PCOS
• Interventions: Drug: Placebo Oral Tablet; Drug: Vitamin D

• Registration Number: NCT03898934
• Lead Sponsor: Tanta University

Brief Summary

To assess whether Vitamin D supplementations for patients with polycystic ovary syndrome in conjunction with clomiphene citrate are beneficial or not

Detailed Description

This study is double blinded randomized controlled study conducted at Tanta University hospitals in the period from April 2019 to March 2022. Patients and methods: One hundred twelve patients were recruited and randomly allocated into 2 groups; study group with Vitamin D supplementation and control group without Vitamin D supplementation.

Study Timeline

• Study First Submitted: 2019-03-30
• Study Start: 2019-04-01
• Study First Submitted QC: 2019-04-01
• Study First Posted: 2019-04-02
• Primary Completion: 2022-03-30
• Study Completion: 2022-03-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-30
• Last Update Posted: 2022-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 170

Inclusion Criteria

• PCOS
• Infertile
• Vitamin D deficient

Exclusion Criteria

• Age less than 20 and more than 35
• Non PCOS patients
• Obese patients
• Previous ovarian surgery
• Previous oophrectomy of one ovary

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo Oral Tablet	These group will receive placebo for the same periods of study group
Vitamin D group	Vitamin D	These patients will receive 6000IU daily for 8 weeks then 2000IU maintenance till pregnancy or end of study

Primary Outcome Measures

Name	Time	Method
Pregnancy rate	3 months	Number of patients who get pregnant
Ovulation rate	3 months	Number of mature follicles obtained

Trial Locations

Locations (1)

Ayman Shehata Dawood; 🇪🇬 Tanta, Algharbia, Egypt