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The effects of cholecalciferol, soy isoflavones, and co-administration of them versus placebo on pain, flatulence and quality of life in patients with irritable bowel syndrome

Protocol summary

Summary
Fasting blood specimens were 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 was 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.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013112915582N1
Registration date: 2014-01-03, 1392/10/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-01-03, 1392/10/13
Registrant information
Name
Mahsa Jalili
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2236 0657
Email address
jalili.mah@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
National Nutrition and Food Technology Institute Digestive Disorders Research Institute
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
The effects of cholecalciferol, soy isoflavones, and co-administration of them versus placebo on pain, flatulence and quality of life in patients with irritable bowel syndrome
Public title
The effects of cholecalciferol and soy isoflavones in irritable bowel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 18-75 yrs; patients with Irritable Bowel Syndrome (IBS) according to ROME III criteria; BMI 18-25; no intestinal organic diseases; no intestinal infection; no history of chronic gastrointestinal and colorectal diseases; no intestinal major surgery; no regular use of antibiotics, anti-constipation and anti-diarrhea, immune suppressors, metocloperamide, cisaperide, difenoxilate, 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: use of soy isoflavones or vitamin D one year before the study; 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
Age
From 18 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
National Nutrition and Food Technology Institute
Street address
Nutrition Faculty of Shahid Beheshti University of Medical Sciences, No. 7, West Argavan Avenue, Shahid Farahzadi Boulevard, Qods Subcity, Tehran
City
Tehran
Postal code
Approval date
2013-11-25, 1392/09/04
Ethics committee reference number
050459

Health conditions studied

1

Description of health condition studied
Irritable Bowel Syndrome
ICD-10 code
K58
ICD-10 code description
Irritable colon

Primary outcomes

1

Description
Clinical Outcomes (pain, flatulence, diarrhea, constipation )
Timepoint
before and after the 6 weeks
Method of measurement
IBS validated Module according to ROME-III criteria

Secondary outcomes

1

Description
gut permeability
Timepoint
before and after 6 weeks
Method of measurement
The fecal serin protease

2

Description
Antioxidant status
Timepoint
before and after 6 weeks
Method of measurement
Serum total antioxidant capacity

3

Description
inflammation status
Timepoint
before and after 6 weeks
Method of measurement
Serum tumor necrosis factor-alpha

Intervention groups

1

Description
Group A receiving Supplement in form of 50000 IU cholecalciferol biweekly for 6 weeks in addition to 40 milligram placebo capsules similar to soy isoflavones including starch 2 capsules per day for 6 weeks
Category
Treatment - Drugs

2

Description
Group B receiving Supplement in form of 40 milligrams soy isoflavones (diadzein, genstein, glycetin) per day (2 capsules of 20 milligrams) for 6 weeks in addition to supplement of cholecalciferol (vitamin D3) biweekly for 6 weeks
Category
Treatment - Drugs

3

Description
Group C 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
Category
Treatment - Drugs

4

Description
Group D receiving oral Placebo in similar form to soy isoflavones (diadzein, genstein, glycetin) supplement including starch (2 capsules per day) for 6 weeks in addition to 50000 IU cholecalciferol supplement biweekly for 6 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Gastrointestinal Clinics of Tehran University of Medical Sciences
Full name of responsible person
Mahsa Jalili
Street address
Digestive Diseases Research Institute, Tehran University of Medical Sciences, Shariati Hospital, North Kargar Avenue, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
National Nutrition and Food Technology Institute
Full name of responsible person
Dr Fateme Mohammadi Nasr abbadi
Street address
Nutrition Faculty, Shahid Beheshti University of Medical Sciences,No. 7, West Argavan Avenue, Farahzadi Boulevard, Qods Subcity, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Nutrition and Food Technology Institute
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

2

Sponsor
Name of organization / entity
Tehran University of Medical Sciences, Digestive Diseases Research Institute
Full name of responsible person
Dr. Reza Malek zadeh
Street address
Shariati Hospital, Jalal-al ahmad Avenue, North Kargar Avenue, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences, Digestive Diseases Research Institute
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Nutrition Faculty of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahsa Jalili
Position
PhD candidate of Nutrition Sciences
Other areas of specialty/work
Street address
No.7, West Argavan Avenue, Farahzadi Boulevard, Qods Subcity, Tehran
City
Tehran
Postal code
Phone
+98 21 2235 7483
Fax
Email
jalili.mah@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nutrition Faculty of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Azita Hekmatdoost
Position
PhD of Nutrition Sciences, MD
Other areas of specialty/work
Street address
Nutrition Faculty of Shahid Beheshti University of Medical Sciences, No.7, West Argavan Avenue, Farahzadi Boulevard, Qods Subcity, Tehran
City
Tehran
Postal code
Phone
+98 21 2235 7483
Fax
Email
a_hekmat2000@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Nutrition Faculty of Shahid University of Medical Sciences
Full name of responsible person
Mahsa Jalili
Position
PhD candidate of Nutrition
Other areas of specialty/work
Street address
Nutrition Faculty of Shahid Beheshti University of Medical Sciences, No.7, West Argavan Avenue, Shahid Farahzadi Boulevard, Qods Subcity, Tehran
City
Tehran
Postal code
Phone
+98 21 2387
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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