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

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).

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Dietary supplement: Vitamin D3 (Cholecalciferol); Dietary supplement: placebo

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 1

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Khuzestan
    • Ahvaz, Khuzestan, Iran, Islamic Republic of, 15794 - 61357
      • Ahvaz Jundishapur University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vitamin D3; 50000 IU vitamin D3 capsule, one capsule every 2 weeks for 6 months.	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.
Placebo Comparator: placebo; Placebo capsule, one capsule every 2 weeks for 6 months.	Dietary supplement: placebo; placebo will be given in identical gelcaps once every 2 weeks for a period of 6 months.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ahvaz Jundishapur University of Medical Sciences

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: October 11, 2015
• First Submitted That Met QC Criteria: October 17, 2015
• First Posted (Estimate): October 20, 2015

Study Record Updates

• Last Update Posted (Estimate): November 30, 2015
• Last Update Submitted That Met QC Criteria: November 27, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Irritable Bowel Syndrome; inflammation; oxidative stress; vitamin D3; clinical signs
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: ir.ajums.rec.1394.306