The effect of vitamin D3 supplementation in treatment of Irritable Bowel Syndrome
Not Applicable
- Conditions
- Irritable bowel syndrome.Irritable colon
- Registration Number
- IRCT2015042521935N1
- Lead Sponsor
- Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
Including criteria: the patients who are 19-60 years old diagnosed with Irritable Bowel Syndrome (IBS) according to ROME III criteria; Signed consent by the patient.
Exclusion criteria: The patients who have celiac disease (diagnosed by a duodenal biopsy or celiac serological tests), any other diseases of the gastrointestinal tract such as 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 improvement of disease signs during the study period.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method TNF-a. Timepoint: Before and after of six months intervention. Method of measurement: ELISA.;IL-10. Timepoint: Before and after of six months intervention. Method of measurement: ELISA.;IL-17. Timepoint: Before and after of six months intervention. Method of measurement: ELISA.;Malondialdehyde (MDA). Timepoint: Before and after of six months intervention. Method of measurement: Thiobarbituric Acid assay.;Total antioxidant capacity (TAC). Timepoint: Before and after of six months intervention. Method of measurement: Colorimetric method.;Serum vitamin D. Timepoint: Before and after of six months intervention. Method of measurement: Radioimmunoassay.;Clinical symptoms (discomfort in the abdomen, abdominal pain, bloating, and disapproval of stool consistency). Timepoint: Baseline and every two weeks for six months. Method of measurement: Rome III questionnaire.;Calcium. Timepoint: Before and after of six months intervention. Method of measurement: Arsenaco III method.
- Secondary Outcome Measures
Name Time Method Weight. Timepoint: Before and after of six months intervention. Method of measurement: Digital scale.;Body Mass Index (BMI). Timepoint: Before and after of six months intervention. Method of measurement: Weight to height squared ratio.;Waist circumference. Timepoint: Before and after of six months intervention. Method of measurement: Tape measure.;Hip circumference. Timepoint: Before and after of six months intervention. Method of measurement: Tape measure.;Physical Activity (PA). Timepoint: Before and after of six months intervention. Method of measurement: Physical activity questionnaire.;Dietary intake. Timepoint: Before and after of three and six months intervention. Method of measurement: 24-hour food recall questionnaire.;Blood pressure. Timepoint: Before and after of six months intervention. Method of measurement: Blood pressure monitor.