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

Primary Purpose

Irritable Bowel Disease

Status
Completed
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Soy isoflavones
cholecalciferol
Placebo of soy isoflavones
placebo of cholecalciferol
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Gastrointestinal Clinics of Tehran University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Arm Label

Soy

Soy- Cholecalciferol

Placebo

Cholecalciferol

Arm 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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 26, 2013
Last Updated
November 17, 2014
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02026518
Brief Title
Effect of Cholecalciferol, Soy Isoflavones in Patients With Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Soy
Arm Type
Experimental
Arm 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
Arm Title
Soy- Cholecalciferol
Arm Type
Experimental
Arm 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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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
Arm Title
Cholecalciferol
Arm Type
Experimental
Arm 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
Intervention Type
Dietary Supplement
Intervention Name(s)
Soy isoflavones
Intervention Type
Dietary Supplement
Intervention Name(s)
cholecalciferol
Other Intervention Name(s)
Vitamin D
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo of soy isoflavones
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo of cholecalciferol
Primary Outcome Measure Information:
Title
Change from baseline in Clinical Outcomes (pain, flatulence, diarrhea, constipation ) at 6 weeks
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change of baseline in gut permeability as efficacy at 6 weeks
Time Frame
6 weeks
Title
Change of baseline in antioxidant status as efficacy at 6 weeks
Time Frame
6 weeks
Title
Change of baseline in inflammation status as efficacy at 6 weeks
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 18-75 yrs patients with Irritable Bowel Syndrome (IBS) according to ROME III criteria BMI 18-25 a- no intestinal organic diseases b- no intestinal infection c- no history of chronic gastrointestinal and colorectal diseases d- no intestinal major surgery no regular use of antibiotics, anti-constipation and anti-diarrhea, immune suppressors, metoclopramide, cisapride, diphenoxylate, opium and non-steroidal anti-inflammatory drugs no pregnancy and lactation not athlete or bed rest no history of breast cancer in herself or her family no severe psychosis Exclusion Criteria: a- use of soy isoflavones or vitamin D one year before the study b- use of soy milk or soy nuts during study diet changes during study use of artificial sweetener 2 days before study no desire to complete the study adverse effect of supplement pregnancy during study
Facility Information:
Facility Name
Gastrointestinal Clinics of Tehran University of Medical Sciences
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
31677711
Citation
Jalili M, Vahedi H, Poustchi H, Hekmatdoost A. Soy isoflavones and cholecalciferol reduce inflammation, and gut permeability, without any effect on antioxidant capacity in irritable bowel syndrome: A randomized clinical trial. Clin Nutr ESPEN. 2019 Dec;34:50-54. doi: 10.1016/j.clnesp.2019.09.003. Epub 2019 Oct 2.
Results Reference
derived
PubMed Identifier
27490103
Citation
Jalili M, Hekmatdoost A, Vahedi H, Poustchi H, Khademi B, Saadi M, Zemestani M, Janani L. Co-Administration of Soy Isoflavones and Vitamin D in Management of Irritable Bowel Disease. PLoS One. 2016 Aug 4;11(8):e0158545. doi: 10.1371/journal.pone.0158545. eCollection 2016.
Results Reference
derived
PubMed Identifier
26396720
Citation
Jalili M, Vahedi H, Janani L, Poustchi H, Malekzadeh R, Hekmatdoost A. Soy Isoflavones Supplementation for Patients with Irritable Bowel Syndrome: A Randomized Double Blind Clinical Trial. Middle East J Dig Dis. 2015 Jul;7:170-6.
Results Reference
derived

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

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