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 Details — Status: Completed

Administrative data

• NCT number: NCT02579902
• Other study ID #: ir.ajums.rec.1394.306
• Status: Completed
• Phase: Phase 1
• First received: October 11, 2015
• Last updated: November 27, 2015
• Start date: February 2015
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: Ahvaz Jundishapur University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

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

• Irritable Bowel Syndrome
• Syndrome

Intervention

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
placebo will be given in identical gelcaps once every 2 weeks for a period of 6 months.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ahvaz Jundishapur University of Medical Sciences	Ahvaz	Khuzestan

Sponsors (1)

Lead Sponsor	Collaborator
Ahvaz Jundishapur University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	Body Weight	Body Weight will be measured in kilograms at baseline and after six months intervention.	up to six months	No
Secondary	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	No
Secondary	Waist Circumference (WC)	WC will be measured in centimeter at baseline and after six months intervention.	up to six months	No
Secondary	Hip Circumference (HC)	HC will be measured in centimeter at baseline and after six months intervention.	up to six months	No
Secondary	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	No
Secondary	Blood Pressure (BP)	BP will be measured in mmHg at baseline and after six months intervention.	up to six months	No
Secondary	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	No
Secondary	Tumor Necrosis Factor-a (TNF-a)	Blood serum TNF-a will be assessed by enzyme-linked immunosorbent assay (ELISA) at baseline and after six months intervention.	up to six months	No
Secondary	Interleukin-10 (IL-10)	Blood serum IL-10 will be assessed by ELISA at baseline and after six months intervention.	up to six months	No
Secondary	Interleukin-17 (IL-17)	Blood serum IL-17 will be assessed by ELISA at baseline and after six months intervention.	up to six months	No
Secondary	Malondialdehyde (MDA)	Blood serum MDA will be assessed by Thiobarbituric acid (TBA) method at baseline and after six months intervention.	up to six months	No
Secondary	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	No
Secondary	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	No
Secondary	Calcium	Blood serum Calcium will be assessed by Arsenazo III method at baseline and after six months intervention	up to six months	No