NCT02579902

Effect of Vitamin D3 Supplementation in Treatment of Irritable Bowel Syndrome

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Ahvaz Jundishapur University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin D3 (Cholecalciferol)	50000 IU Vitamin D3 (Cholecalciferol) will be given as one gelcaps every 2 weeks for a period of 6 months.
DIETARY_SUPPLEMENT	placebo	placebo will be given in identical gelcaps once every 2 weeks for a period of 6 months.

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-08-01
• Completion: 2015-09-01
• First posted: 2015-10-20
• Last updated: 2015-11-30

Locations

1 site across 1 country: Iran