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The Effect of Calcium and Vitamin D Supplements on Metabolic and Hormonal Disturbances in Polycystic Ovary Syndrome Patients

NCT03792984 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-06-06

No results posted yet for this study

Summary

The aim of this study is to investigate the safety and metabolic-hormonal efficiency of supplementation vitamin D deficient/insufficient PCOS women with (calcium +vitamin D + metformin) for 8 weeks compared to (placebo+ metformin).

Conditions

  • Polycystic Ovary Syndrome
  • Vitamin D Deficiency/Insufficiency

Interventions

DIETARY_SUPPLEMENT

Vitamin D3

Vitamin D3 (Cholecalciferol) (6000 IU/daily). PO for 8 weeks.

DIETARY_SUPPLEMENT

Calcium Carbonate

Calcium carbonate (1000 mg/daily). PO for 8 weeks.

DRUG

Metformin

Metformin (1500 mg/daily; the metformin dose was increased stepwise, starting with 500 mg once daily for the 1st week, 500 mg twice daily in the 2nd week, followed by 500 mg 3 times daily from the 3rd week onward). PO for 8 weeks.

DRUG

Placebo

PO for 8 weeks.

Sponsors & Collaborators

  • Damascus University

    lead OTHER

Principal Investigators

  • Sally Kadoura, B Pharm, MD · Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Damascus University, Damascus, Syria

  • Abdul Hakim Nattouf, MD, PhD · Professor at Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Damascus University, Damascus, Syria

  • Marwan Alhalabi, MD, PhD · Professor at Department of Embryology and Reproductive Medicine, Faculty of Medicine, Damascus University, Damascus, Syria.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-01
Primary Completion
2017-10-01
Completion
2017-12-30

Countries

  • Syria

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03792984 on ClinicalTrials.gov