Effect of Cholecalciferol, Soy Isoflavones in Patients With Irritable Bowel Syndrome

Phase 4

Completed

• Conditions: Irritable Bowel Disease
• Interventions: Dietary Supplement: Soy isoflavones; Dietary Supplement: cholecalciferol; Dietary Supplement: Placebo of soy isoflavones; Dietary Supplement: placebo of cholecalciferol

• Registration Number: NCT02026518
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-26
• Study First Submitted QC: 2013-12-31
• Study Start: 2014-01
• Study First Posted: 2014-01-03
• Primary Completion: 2014-04
• Study Completion: 2014-06
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1. age 18-75 yrs
2. patients with Irritable Bowel Syndrome (IBS) according to ROME III criteria
3. BMI 18-25
4. a- no intestinal organic diseases b- no intestinal infection c- no history of chronic gastrointestinal and colorectal diseases d- no intestinal major surgery
5. no regular use of antibiotics, anti-constipation and anti-diarrhea, immune suppressors, metoclopramide, cisapride, diphenoxylate, opium and non-steroidal anti-inflammatory drugs
6. no pregnancy and lactation
7. not athlete or bed rest
8. no history of breast cancer in herself or her family
9. no severe psychosis

Exclusion Criteria

1. a- use of soy isoflavones or vitamin D one year before the study b- use of soy milk or soy nuts during study
2. diet changes during study
3. use of artificial sweetener 2 days before study
4. no desire to complete the study
5. adverse effect of supplement
6. pregnancy during study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Soy	Soy isoflavones	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
Soy- Cholecalciferol	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
Cholecalciferol	Placebo of soy isoflavones	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
Soy- Cholecalciferol	Soy isoflavones	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
Soy	placebo of cholecalciferol	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
Cholecalciferol	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
Placebo	Placebo of soy isoflavones	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
Placebo	placebo of 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

Primary Outcome Measures

Name	Time	Method
Change from baseline in Clinical Outcomes (pain, flatulence, diarrhea, constipation ) at 6 weeks	6 weeks

Secondary Outcome Measures

Name	Time	Method
Change of baseline in antioxidant status as efficacy at 6 weeks	6 weeks
Change of baseline in gut permeability as efficacy at 6 weeks	6 weeks
Change of baseline in inflammation status as efficacy at 6 weeks	6 weeks

Trial Locations

Locations (1)

Gastrointestinal Clinics of Tehran University of Medical Sciences; 🇮🇷 Tehran, Iran, Islamic Republic of