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IRCT2015042521935N1 IRCT 2015-10-27 Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences The effect of vitamin D3 supplementation in treatment of Irritable Bowel Syndrome Evaluating the effect of vitamin D3 supplementation on clinical signs, inflammatory and oxidative stress bio-markers in patients with Irritable Bowel Syndrome: A randomized double blinded clinical trial 2015-05-26 anticipated 90 Complete https://irct.ir/trial/19065 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A Irritable bowel syndrome. Intervention 1: Intervention group: Cholecalciferol (vitamin D3) 50000 IU, once every two weeks, for six months. Intervention 2: Control group: Edible paraffin as placebo, once every two weeks, for six months.
public Amir Abbasnezhad
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd. Ahvaz
Ahvaz Iran (Islamic Republic of) +98 61 3373 8319 abbasnezhad91@gmail.com Ahvaz Jundishapur University Of Medical Sciences scientific Reza Amani
Ahvaz Judishapur University of Medical Sciences, Golestan Blvd. Ahvaz
Ahvaz Iran (Islamic Republic of) +98 61 3373 8319 rezaamani@hotmail.com Ahvaz Judishapur University of Medical Sciences Iran (Islamic Republic of) 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. 19 years 60 years Both k58 Irritable colon Treatment - Drugs Treatment - Drugs Intervention group: Cholecalciferol (vitamin D3) 50000 IU, once every two weeks, for six months Control group: Edible paraffin as placebo, once every two weeks, for six months TNF-α. 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. 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. Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences Approved 2015-05-25 Ethics Committee of Ahvaz Jundishapur University Of Medical Sciences Ahvaz Jundishapur University Of Medical Sciences, Golestan Blvd. Ahvaz Ahvaz Iran (Islamic Republic of)