A Phase 4 interventional study of Soy isoflavones and cholecalciferol in Irritable Bowel Disease, sponsored by Shahid Beheshti University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-11-18.
Sponsored by Shahid Beheshti University of Medical Sciences · Phase 4, Interventional, and Treatment
Fasting blood specimens will be taken from the patients with IBS that have inclusion criteria. First, the objectives and method of study will be explained to the patients and informed consent form will be taken from them. They will be divided into 4 groups by an adjusted randomized blocking and the clinical outcomes, quality of life, emotional stress questionnaires will be completed before and after intervention. During 6 weeks, they will receive 2 capsules of soy isoflavones per day, 50000IU vitamin D biweekly in addition to the other placebo form, both of them and placebo of both. At the end, body mass index ( BMI), serum TNF-Alpha, TAC, gene expression of GATA3, ROR gamma, FOXP3 in lymphocytes and gut permeability will be measured. The quantity of polymorphisms of vitamin D and estrogen receptors will be determined.
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's enrollment of 100 is above the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Shahid Beheshti University of Medical Sciences is the lead sponsor of 221 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Group Soy receiving placebo similar to 50000 IU cholecalciferol (includes MCT oil) biweekly for 6 weeks in addition to 40 milligram (2 capsules per day) soy isoflavones capsules for 6 weeks
Dietary Supplement: Soy isoflavones · Dietary Supplement: placebo of cholecalciferol
Group Soy- Cholecalciferol receiving Supplement in form of 40 milligrams soy isoflavones (diadzein, genistein, glycitin) per day (2 capsules of 20 milligrams) for 6 weeks in addition to supplement of cholecalciferol (vitamin D3) biweekly for 6 weeks
Dietary Supplement: Soy isoflavones · Dietary Supplement: cholecalciferol
Group Placebo 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
Dietary Supplement: Placebo of soy isoflavones · Dietary Supplement: placebo of cholecalciferol
Group Cholecalciferol receiving oral Placebo in similar form to soy isoflavones (diadzein, genistein, glycitin) supplement including starch (2 capsules per day) for 6 weeks in addition to 50000 IU cholecalciferol supplement biweekly for 6 weeks
Dietary Supplement: cholecalciferol · Dietary Supplement: Placebo of soy isoflavones
Also known as: Vitamin D
Change from baseline in Clinical Outcomes (pain, flatulence, diarrhea, constipation ) at 6 weeks
Time frame: 6 weeks
Change of baseline in gut permeability as efficacy at 6 weeks
Time frame: 6 weeks
Change of baseline in antioxidant status as efficacy at 6 weeks
Time frame: 6 weeks
Change of baseline in inflammation status as efficacy at 6 weeks
Time frame: 6 weeks
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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Shahid Beheshti University of Medical Sciences