Effect of Vitamin D3 Supplementation in Treatment of Irritable Bowel Syndrome

Ahvaz Jundishapur University of Medical Sciences90 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Irritable Bowel Syndrome

Interventions

Vitamin D3 (Cholecalciferol)DIETARY_SUPPLEMENT

50000 IU Vitamin D3 (Cholecalciferol) will be given as one gelcaps every 2 weeks for a period of 6 months.

placeboDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ahvaz Jundishapur University of Medical Sciences

Ahvāz, Khuzestan, Iran

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: up to six months

Secondary Outcomes

Dietary intake

24-Hour dietary recalls questionnaires will be used to assess dietary pattern at baseline and after 3 and 6 months intervention.

Time frame: up to six months

Body Weight

Body Weight will be measured in kilograms at baseline and after six months intervention.

Time frame: 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.

Time frame: up to six months

Waist Circumference (WC)

WC will be measured in centimeter at baseline and after six months intervention.

Time frame: up to six months

Hip Circumference (HC)

HC will be measured in centimeter at baseline and after six months intervention.

Time frame: up to six months

Data from ClinicalTrials.gov

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