Effect of Vitamin D3 Supplementation in Treatment of Irritable Bowel Syndrome

Study Overview
=================
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.

Official Title
-----------------
Effect of Vitamin D3 Supplementation on Clinical Signs, Oxidative Stress and Inflammatory Biomarkers in Patients With Irritable Bowel Syndrome

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin D3 (Cholecalciferol)
* Dietary Supplement: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin D3<br>50000 IU vitamin D3 capsule, one capsule every 2 weeks for 6 months. | Dietary Supplement: Vitamin D3 (Cholecalciferol)<br>* 50000 IU Vitamin D3 (Cholecalciferol) will be given as one gelcaps every 2 weeks for a period of 6 months.<br>|
| Placebo Comparator: placebo<br>Placebo capsule, one capsule every 2 weeks for 6 months. | Dietary Supplement: placebo<br>* placebo will be given in identical gelcaps once every 2 weeks for a period of 6 months.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Irritable Bowel Syndrome, inflammation, oxidative stress, clinical signs, vitamin D3