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

Shahid Beheshti University of Medical Sciences

Status and phase: Completed; Phase 4

Conditions: Irritable Bowel Disease

Treatments: Dietary Supplement: placebo of cholecalciferol; Dietary Supplement: cholecalciferol; Dietary Supplement: Soy isoflavones; Dietary Supplement: Placebo of soy isoflavones

Study type: Interventional

Funder types: Other

Identifiers

NCT02026518

459

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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100 participants in 4 patient groups, including a placebo group

Soy

Experimental group

Description:

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

Treatment:

Dietary Supplement: placebo of cholecalciferol

Dietary Supplement: Soy isoflavones

Soy- Cholecalciferol

Experimental group

Description:

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

Treatment:

Dietary Supplement: Soy isoflavones

Dietary Supplement: cholecalciferol

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo of soy isoflavones

Dietary Supplement: placebo of cholecalciferol

Cholecalciferol

Experimental group

Description:

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

Treatment:

Dietary Supplement: Placebo of soy isoflavones

Dietary Supplement: cholecalciferol