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The Effect of Vitamin D Supplementation Among Overweight Jordanian Women With Polycystic Ovary Syndrome

Polycystic Ovary Syndrome Clinical Trial

Official title:
The Effect of Vitamin D Supplementation on Chromium Serum Levels and Insulin Resistance Among Overweight Jordanian Women With Polycystic Ovary Syndrome in Irbid

Clinical Trial Summary

The purpose of this study is to examine the effect of 50,000 IU vitamin D3 supplementation on Polycystic Ovary Syndrome prognosis.

A randomized, double-blind, Parallel design comparing vitamin D with Placebo will be conducted on 60 overweight females diagnosed with PCOS according to Rotterdam criteria and have serum 25(OH)D level < 20 ng/ml. The results are expected to assess the improvement of Polycystic Ovary Syndrome prognosis and the effect of Vitamin D Supplementation on Chromium Serum Levels and Insulin Resistance.

Clinical Trial Description

controlled randomised double blind study to examine the Effect of Vitamin D Supplementation on Chromium Serum Levels and Insulin Resistance among Overweight Jordanian Women with Polycystic Ovary Syndrome in Irbid. comparing vitamin D with Placebo will be conducted on 60 overweight females diagnosed with PCOS according to Rotterdam criteria and have serum 25(OH)D level < 20 ng/ml. Evaluation of the effectiveness of the dose regimen considered in this study as the product SmPC which will be measured through the assessment of serum 25 (OH)D along the trial period. the expected duration of participants participation will be around 104 days divided on 6 visits. the first visit will be 7 days before the beginning of the study, the second will be at day 0 of the trial to measure the baseline, third vist at day 30, then at day 60, then at day 90 and the final visit will be after 104 days of study. The results are expected to assess the improvement of PCOS prognosis and the effect of Vitamin D Supplementation on Chromium Serum Levels and Insulin Resistance. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02328404
Study type Interventional
Source Hayat Pharmaceutical Co. PLC
Contact
Status Completed
Phase Phase 3
Start date February 2014
View Details
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