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Effect of Vitamin D3 Supplementation in Treatment of Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:
Effect of Vitamin D3 Supplementation on Clinical Signs, Oxidative Stress and Inflammatory Biomarkers in Patients With Irritable Bowel Syndrome

Clinical Trial Summary

The purpose of this study is to determine whether vitamin D3 supplementation is effective in the treatment of clinical signs, biomarkers of inflammation and oxidative stress due to Irritable Bowel Syndrome (IBS).

Clinical Trial Description

This randomized double blind clinical trial will be performed on 90 patients (45 in intervention and 45 in control group) diagnosed with IBS. The intervention group will receive 50000 IU vitamin D3 and the control group will receive placebo contains edible paraffin once every 2 weeks for six months. Variables including biomarkers of inflammation and oxidative stress, serum levels of calcium and vitamin D, anthropometric indicators and blood pressure will be measured at baseline and end of the study. The investigators will use Rome III questionnaire for evaluating the clinical signs of the disease. The questionnaires will be filled out at baseline and every 2 weeks by the patients for six months. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02579902
Study type Interventional
Source Ahvaz Jundishapur University of Medical Sciences
Contact
Status Completed
Phase Phase 1
Start date February 2015
Completion date September 2015
View Details
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