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

Irritable Bowel Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02026518
• Other study ID #: 459
• Status: Completed
• Phase: Phase 4
• First received: December 26, 2013
• Last updated: November 17, 2014
• Start date: January 2014
• Est. completion date: June 2014

Study information

• Verified date: November 2014
• Source: hahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Disease
• Irritable Bowel Syndrome

Intervention

Dietary Supplement:
• Soy isoflavones

• cholecalciferol

• Placebo of soy isoflavones

• placebo of cholecalciferol

Locations

Country	Name	City	State
Iran, Islamic Republic of	Gastrointestinal Clinics of Tehran University of Medical Sciences	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Clinical Outcomes (pain, flatulence, diarrhea, constipation ) at 6 weeks		6 weeks	Yes
Secondary	Change of baseline in gut permeability as efficacy at 6 weeks		6 weeks	No
Secondary	Change of baseline in antioxidant status as efficacy at 6 weeks		6 weeks	No
Secondary	Change of baseline in inflammation status as efficacy at 6 weeks		6 weeks	No