PCOvit-D: Vitamin D Supplementation in PCOS Patients

Sponsor

Tanta University (Other)

Overall Status

Completed

CT.gov ID

NCT03898934

Collaborator

(none)

170

Enrollment

Location

Arms

Actual Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
PCOS	Drug: Vitamin D Drug: Placebo Oral Tablet	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

170 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The 2 groups will be treated at the same timeThe 2 groups will be treated at the same time

Masking:

Double (Participant, Care Provider)

Masking Description:

Both patients and gynecologists were binded

Primary Purpose:

Treatment

Official Title:

Dose Vitamin-D Supplementation Affect Reproductive Outcomes in Patients With Polycystic Ovary Syndrome?

Actual Study Start Date :

Apr 1, 2019

Actual Primary Completion Date :

Mar 30, 2022

Actual Study Completion Date :

Mar 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vitamin D group These patients will receive 6000IU daily for 8 weeks then 2000IU maintenance till pregnancy or end of study	Drug: Vitamin D receive 6000iu daily for 8 weeks
Placebo Comparator: Placebo group These group will receive placebo for the same periods of study group	Drug: Placebo Oral Tablet placebo for the same period

Arm

Intervention/Treatment

Experimental: Vitamin D group

These patients will receive 6000IU daily for 8 weeks then 2000IU maintenance till pregnancy or end of study

Drug: Vitamin D

receive 6000iu daily for 8 weeks

Placebo Comparator: Placebo group

These group will receive placebo for the same periods of study group

Drug: Placebo Oral Tablet

placebo for the same period

Outcome Measures

Primary Outcome Measures

Ovulation rate [3 months]
Number of mature follicles obtained
Pregnancy rate [3 months]
Number of patients who get pregnant

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ayman Shehata Dawood	Tanta	Algharbia	Egypt	31111

Sponsors and Collaborators

Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ayman S Dawood, MD, Lecturer, Tanta University

ClinicalTrials.gov Identifier:

NCT03898934

Other Study ID Numbers:

PCOvit-D

First Posted:

Apr 2, 2019

Last Update Posted:

May 5, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ayman S Dawood, MD, Lecturer, Tanta University

Additional relevant MeSH terms:

Vitamin D

Study Results

No Results Posted as of May 5, 2022