Vitamin D Supplementation in PCOS Patients

NCT ID: NCT03898934

Last Updated: 2022-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2022-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

PCOS

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The 2 groups will be treated at the same time
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
Both patients and gynecologists were binded

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vitamin D group

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

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DRUG

receive 6000iu daily for 8 weeks

Placebo group

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

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

placebo for the same period

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vitamin D

receive 6000iu daily for 8 weeks

Intervention Type DRUG

Placebo Oral Tablet

placebo for the same period

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tanta University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ayman S Dawood, MD

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ayman Shehata Dawood

Tanta, Algharbia, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PCOvit-D

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Oral Administration of DCI to Women With PCOS
NCT00497653 TERMINATED PHASE2/PHASE3