Irritable bowel syndrome. Irritable colon
Conditions
Interventions
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 si
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
Sponsors
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Eligibility
Sex/Gender
All
Age
19 Years to 60 Years
Inclusion criteria
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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAmir Abbasnezhad
Ahvaz Jundishapur University Of Medical Sciences
Outcome results
None listed