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Effect of Cholecalciferol, So...

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

NCT ID: NCT02026518

Last Updated: 2014-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-06-30

Brief Summary

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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

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Conditions

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Irritable Bowel Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Soy isoflavones

Intervention Type DIETARY_SUPPLEMENT

placebo of cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

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

Group Type EXPERIMENTAL

Soy isoflavones

Intervention Type DIETARY_SUPPLEMENT

cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

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

Group Type PLACEBO_COMPARATOR

Placebo of soy isoflavones

Intervention Type DIETARY_SUPPLEMENT

placebo of cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

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

Group Type EXPERIMENTAL

cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

Placebo of soy isoflavones

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Soy isoflavones

Intervention Type DIETARY_SUPPLEMENT

cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

Placebo of soy isoflavones

Intervention Type DIETARY_SUPPLEMENT

placebo of cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Vitamin D

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Mahsa Jalili

Mrs

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gastrointestinal Clinics of Tehran University of Medical Sciences

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

References

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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.

Reference Type DERIVED

PMID: 31677711 (View on PubMed)

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.

Reference Type DERIVED

PMID: 27490103 (View on PubMed)

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.

Reference Type DERIVED

PMID: 26396720 (View on PubMed)

Other Identifiers

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459

Identifier Type: -

Identifier Source: org_study_id