Effect of Vitamin D3 Supplementation in Treatment of Irritable Bowel Syndrome

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).

Full Title of Study: “Effect of Vitamin D3 Supplementation on Clinical Signs, Oxidative Stress and Inflammatory Biomarkers in Patients With Irritable Bowel Syndrome”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2015

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Active Comparator: Vitamin D3
    • 50000 IU vitamin D3 capsule, one capsule every 2 weeks for 6 months.
  • Placebo Comparator: placebo
    • Placebo capsule, one capsule every 2 weeks for 6 months.

Clinical Trial Outcome Measures

Primary Measures

  • Clinical signs including abdominal pain, bloating, rumbling, abdominal distention, dissatisfaction with stool consistency
    • Time Frame: 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.
  • Symptom Severity Score
    • Time Frame: 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.

Secondary Measures

  • Dietary intake
    • Time Frame: 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.
  • Body Weight
    • Time Frame: up to six months
    • Body Weight will be measured in kilograms at baseline and after six months intervention.
  • Body Mass Index (BMI)
    • Time Frame: 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.
  • Waist Circumference (WC)
    • Time Frame: up to six months
    • WC will be measured in centimeter at baseline and after six months intervention.
  • Hip Circumference (HC)
    • Time Frame: up to six months
    • HC will be measured in centimeter at baseline and after six months intervention.
  • Waist to Hip Ratio (WHR)
    • Time Frame: up to six months
    • WHR is WC divided to HC. It will be measured at baseline and after six months intervention.
  • Blood Pressure (BP)
    • Time Frame: up to six months
    • BP will be measured in mmHg at baseline and after six months intervention.
  • Health-related Quality of Life
    • Time Frame: 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.
  • Tumor Necrosis Factor-α (TNF-α)
    • Time Frame: 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)
    • Time Frame: up to six months
    • Blood serum IL-10 will be assessed by ELISA at baseline and after six months intervention.
  • Interleukin-17 (IL-17)
    • Time Frame: up to six months
    • Blood serum IL-17 will be assessed by ELISA at baseline and after six months intervention.
  • Malondialdehyde (MDA)
    • Time Frame: up to six months
    • Blood serum MDA will be assessed by Thiobarbituric acid (TBA) method at baseline and after six months intervention.
  • Total Antioxidant Capacity (TAC)
    • Time Frame: up to six months
    • Blood serum TAC will be assessed by Ferric Reducing Antioxidant Power (FRAP) assay at baseline and after six months intervention.
  • 25-hydroxy vitamin D (25(OH)D)
    • Time Frame: up to six months
    • Blood serum 25(OH)D will be assessed by Radioimmunoassay at baseline and after six months intervention.
  • Calcium
    • Time Frame: up to six months
    • Blood serum Calcium will be assessed by Arsenazo III method at baseline and after six months intervention

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ahvaz Jundishapur University of Medical Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Amir Abbasnezhad, Ph.D candidate of Nutrition Sciences – Ahvaz Jundishapur University of Medical Sciences

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