The effects of cholecalciferol and soy isoflavones in irritable bowel syndrome

INTERVENTION: Group A receiving Supplement in form of 50000 IU cholecalciferol biweekly for 6 weeks in addition to 40 milligram placebo capsules similar to soy isoflavones including starch 2 capsules per day for 6 weeks Group B receiving Supplement in form of 40 milligrams soy isoflavones (diadzein, genstein, glycetin) per day (2 capsules of 20 milligrams) for 6 weeks in addition to supplement of cholecalciferol (vitamin D3) biweekly for 6 weeks Group C receiving Placebo in similar form of cholecalciferol supplement biweekly for 6 weeks in addition to 40 milligrams placebo in similar form of soy isoflavones including starch for 6 weeks Group D receiving oral Placebo in similar form to soy isoflavones (diadzein, genstein, glycetin) supplement including starch (2 capsules per day) for 6 weeks in addition to 50000 IU cholecalciferol supplement biweekly for 6 weeks Intervention 1: Group A receiving Supplement in form of 50000 IU cholecalciferol biweekly for 6 weeks in addition to 40 milligram placebo capsules similar to soy isoflavones including starch 2 capsules per day for 6 weeks. Intervention 2: Group B receiving Supplement in form of 40 milligrams soy isoflavones (diadzein, genstein, glycetin) per day (2 capsules of 20 milligrams) for 6 weeks in addition to supplement of cholecalciferol (vitamin D3) biweekly for 6 weeks. Intervention 3: Group C receiving Placebo in similar form of cholecalciferol supplement biweekly for 6 weeks in addition to 40 milligrams placebo in similar form of soy isoflavones including starch for 6 weeks. Intervention 4: Group D receiving oral Placebo in similar form to soy isoflavones (diadzein, genstein, glycetin) supplement including starch (2 capsules per day) for 6 weeks in addition to 50000 IU cholecalciferol supplement biweekly for 6 weeks. Treatment ‐ Drugs CONDITION: Irritable Bowel Syndrome. ; Irritable colon Irritable colon PRIMARY OUTCOME: Clinical Outcomes (pain, flatulence, diarrhea, constipation ). Timepoint: before and after the 6 weeks. Method of measurement: IBS validated Module according to ROME‐III criteria. SECONDARY OUTCOME: Antioxidant status. Timepoint: before and after 6 weeks. Method of measurement: Serum total antioxidant capacity. Gut permeability. Timepoint: before and after 6 weeks. Method of measurement: The fecal serin protease. Inflammation status. Timepoint: before and after 6 weeks. Method of measurement: Serum tumor necrosis factor‐alpha. INCLUSION CRITERIA: INCLUSION CRITERIA: age 18‐75 yrs; patients with Irritable Bowel Syndrome (IBS) according to ROME III criteria; BMI 18‐25; no intestinal organic diseases; no intestinal infection; no history of chronic gastrointestinal and colorectal diseases; no intestinal major surgery; no regular use of antibiotics, anti‐constipation and anti‐diarrhea, immune suppressors, metocloperamide, cisaperide, difenoxilate, opium and non‐steroidal anti‐inflammatory drugs; no pregnancy and lactation; not athlete or bed rest; no history of breast cancer in herself or her family; no severe psychosis Exclusion criteria: use of soy isoflavones or vitamin D one year before the study; use of soy milk or soy nuts during study; diet changes during study; use of artificial sweetener 2 days before study; no desire to complete the study; adverse effect of supplement; pregnancy during study