Effect of Vitamin D3 Supplementation in Treatment of Irritable Bowel Syndrome

Phase 1

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Dietary Supplement: Vitamin D3 (Cholecalciferol); Dietary Supplement: placebo

• Registration Number: NCT02579902
• Lead Sponsor: Ahvaz Jundishapur University of Medical Sciences

Brief 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.

Study Timeline

• Study Start: 2015-02
• Primary Completion: 2015-08
• Study Completion: 2015-09
• Study First Submitted: 2015-10-11
• Study First Submitted QC: 2015-10-17
• Study First Posted: 2015-10-20
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-27
• Last Update Posted: 2015-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• The patients who are diagnosed with Irritable Bowel Syndrome (IBS) according to ROME III criteria; Signed consent by the patient.

Exclusion Criteria

• Patients who have celiac disease (diagnosed by a duodenal biopsy or celiac serological tests)
• Any other diseases of the gastrointestinal tract such as Inflammatory Bowel Disease (IBD)
• Any kind of abdominal surgery
• Chronic disease such as diabetes
• Cardiovascular, hepatic
• Kidney and severe infection
• Pregnancy
• Breastfeeding
• Smoking
• Alcohol consumption
• Use of dietary supplements
• Use of vitamin D and calcium supplement during the last year before the study
• Use any medication for signs improvement during the study period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D3	Vitamin D3 (Cholecalciferol)	50000 IU vitamin D3 capsule, one capsule every 2 weeks for 6 months.
placebo	placebo	Placebo capsule, one capsule every 2 weeks for 6 months.

Primary Outcome Measures

Name	Time	Method
Symptom Severity Score	up to six months	symptom severity score will be assessed by IBS-Symptom Severity Score (IBS-SSS) self-report questionnaire baseline and after six months intervention.
Clinical signs including abdominal pain, bloating, rumbling, abdominal distention, dissatisfaction with stool consistency	up to six months	clinical signs will be assessed by Visual Analog Scale (VAS) 0-100mm self-report questionnaire at baseline and every two weeks for six months.

Secondary Outcome Measures

Name	Time	Method
Dietary intake	up to six months	24-Hour dietary recalls questionnaires will be used to assess dietary pattern at baseline and after 3 and 6 months intervention.
Waist Circumference (WC)	up to six months	WC will be measured in centimeter at baseline and after six months intervention.
Body Weight	up to six months	Body Weight will be measured in kilograms at baseline and after six months intervention.
Tumor Necrosis Factor-α (TNF-α)	up to six months	Blood serum TNF-α will be assessed by enzyme-linked immunosorbent assay (ELISA) at baseline and after six months intervention.
Interleukin-10 (IL-10)	up to six months	Blood serum IL-10 will be assessed by ELISA at baseline and after six months intervention.
Interleukin-17 (IL-17)	up to six months	Blood serum IL-17 will be assessed by ELISA at baseline and after six months intervention.
Total Antioxidant Capacity (TAC)	up to six months	Blood serum TAC will be assessed by Ferric Reducing Antioxidant Power (FRAP) assay at baseline and after six months intervention.
Waist to Hip Ratio (WHR)	up to six months	WHR is WC divided to HC. It will be measured at baseline and after six months intervention.
Blood Pressure (BP)	up to six months	BP will be measured in mmHg at baseline and after six months intervention.
Body Mass Index (BMI)	up to six months	BMI is weight in kilograms divided to height in meters squared. It will be measured at baseline and after six months intervention.
Hip Circumference (HC)	up to six months	HC will be measured in centimeter at baseline and after six months intervention.
Health-related Quality of Life	up to six months	Health-Related Quality of Life will be assessed by IBS-Quality Of Life (IBS-QOL) with 34-item Short-Form (SF-34) self-report questionnaire at baseline and after six months intervention.
Malondialdehyde (MDA)	up to six months	Blood serum MDA will be assessed by Thiobarbituric acid (TBA) method at baseline and after six months intervention.
Calcium	up to six months	Blood serum Calcium will be assessed by Arsenazo III method at baseline and after six months intervention
25-hydroxy vitamin D (25(OH)D)	up to six months	Blood serum 25(OH)D will be assessed by Radioimmunoassay at baseline and after six months intervention.

Trial Locations

Locations (1)

Ahvaz Jundishapur University of Medical Sciences; 🇮🇷 Ahvaz, Khuzestan, Iran, Islamic Republic of