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

Sponsor
Shahid Beheshti University of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT02026518
Collaborator
(none)
100
Enrollment
1
Location
4
Arms
5
Duration (Months)
20.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Soy isoflavones
  • Dietary Supplement: cholecalciferol
  • Dietary Supplement: Placebo of soy isoflavones
  • Dietary Supplement: placebo of cholecalciferol
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Apr 1, 2014
Actual Study Completion Date :
Jun 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Soy

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
Experimental: Soy- 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
Other Names:
  • Vitamin D

    		•
    Placebo Comparator: Placebo

    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
    Experimental: 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
    Other Names:
  • Vitamin D

    • Dietary Supplement: Placebo of soy isoflavones

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in Clinical Outcomes (pain, flatulence, diarrhea, constipation ) at 6 weeks [6 weeks]

    Secondary Outcome Measures

    1. Change of baseline in gut permeability as efficacy at 6 weeks [6 weeks]

    2. Change of baseline in antioxidant status as efficacy at 6 weeks [6 weeks]

    3. Change of baseline in inflammation status as efficacy at 6 weeks [6 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gastrointestinal Clinics of Tehran University of Medical Sciences Tehran Iran, Islamic Republic of

    Sponsors and Collaborators

    • Shahid Beheshti University of Medical Sciences

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mahsa Jalili, Mrs, Shahid Beheshti University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT02026518
    Other Study ID Numbers:
    • 459
    First Posted:
    Jan 3, 2014
    Last Update Posted:
    Nov 18, 2014
    Last Verified:
    Nov 1, 2014
    Additional relevant MeSH terms:
    Irritable Bowel Syndrome
    Vitamin D
    Cholecalciferol

    Study Results

    No Results Posted as of Nov 18, 2014