Evaluating the effect of vitamin D3 supplementation on clinical signs, inflammatory and oxidative stress bio-markers in patients with Irritable Bowel Syndrome: A randomized double blinded clinical trial
The purpose of this study is to evaluate the effect of vitamin D supplementation on markers of inflammation and oxidative stress and clinical signs in patients with Irritable Bowel Syndrome (IBS). This randomized double blind clinical trial will be performed on 90 patients (45 in intervention and 45 in control group) with IBS. The intervention group will receive 50000 IU vitamin D3 and the control group will receive placebo contains edible paraffin once every two weeks for six months. Variables including markers of inflammation and oxidative stress, serum levels of calcium and vitamin D3, anthropometric indicators and blood pressure will be measured at baseline and end of the study. We will use Rome III questionnaire for evaluating the clinical signs of the disease. The questionnaires will be filled out at baseline and every two weeks by the patients for six months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015042521935N1
Registration date:2015-10-27, 1394/08/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-27, 1394/08/05
Registrant information
Name
Amir Abbasnezhad
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 443440992
Email address
abbasnezhad91@gmail.com
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2015-05-26, 1394/03/05
Expected recruitment end date
2015-11-25, 1394/09/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of vitamin D3 supplementation on clinical signs, inflammatory and oxidative stress bio-markers in patients with Irritable Bowel Syndrome: A randomized double blinded clinical trial
Public title
The effect of vitamin D3 supplementation in treatment of Irritable Bowel Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Including criteria: the patients who are 19-60 years old diagnosed with Irritable Bowel Syndrome (IBS) according to ROME III criteria; Signed consent by the patient.
Exclusion criteria: The patients who have celiac disease (diagnosed by a duodenal biopsy or celiac serological tests), any other diseases of the gastrointestinal tract such as IBD, any kind of abdominal surgery, chronic disease such as diabetes, cardiovascular, hepatic, kidney and severe infection; Pregnancy; Breastfeeding; Smoking; Alcohol consumption; Use of dietary supplements; Use of vitamin D and calcium supplement during the last year before the study; Use any medication for improvement of disease signs during the study period.
Age
From 19 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University Of Medical Sciences
Street address
Ahvaz Jundishapur University Of Medical Sciences, Golestan Blvd. Ahvaz
City
Ahvaz
Postal code
Approval date
2015-05-25, 1394/03/04
Ethics committee reference number
ir.ajums.rec.1394.306
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
TNF-α
Timepoint
Before and after of six months intervention
Method of measurement
ELISA
2
Description
IL-10
Timepoint
Before and after of six months intervention
Method of measurement
ELISA
3
Description
IL-17
Timepoint
Before and after of six months intervention
Method of measurement
ELISA
4
Description
Malondialdehyde (MDA)
Timepoint
Before and after of six months intervention
Method of measurement
Thiobarbituric Acid assay
5
Description
Total antioxidant capacity (TAC)
Timepoint
Before and after of six months intervention
Method of measurement
Colorimetric method
6
Description
Serum vitamin D
Timepoint
Before and after of six months intervention
Method of measurement
Radioimmunoassay
7
Description
Clinical symptoms (discomfort in the abdomen, abdominal pain, bloating, and disapproval of stool consistency)
Timepoint
Baseline and every two weeks for six months
Method of measurement
Rome III questionnaire
8
Description
Calcium
Timepoint
Before and after of six months intervention
Method of measurement
Arsenaco III method
Secondary outcomes
1
Description
Weight
Timepoint
Before and after of six months intervention
Method of measurement
Digital scale
2
Description
Body Mass Index (BMI)
Timepoint
Before and after of six months intervention
Method of measurement
Weight to height squared ratio
3
Description
Waist circumference
Timepoint
Before and after of six months intervention
Method of measurement
Tape measure
4
Description
Hip circumference
Timepoint
Before and after of six months intervention
Method of measurement
Tape measure
5
Description
Physical Activity (PA)
Timepoint
Before and after of six months intervention
Method of measurement
Physical activity questionnaire
6
Description
Dietary intake
Timepoint
Before and after of three and six months intervention
Method of measurement
24-hour food recall questionnaire
7
Description
Blood pressure
Timepoint
Before and after of six months intervention
Method of measurement
Blood pressure monitor
Intervention groups
1
Description
Intervention group: Cholecalciferol (vitamin D3) 50000 IU, once every two weeks, for six months
Category
Treatment - Drugs
2
Description
Control group: Edible paraffin as placebo, once every two weeks, for six months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Imam Khomeini Hospital
Full name of responsible person
Street address
Ahvaz Imam Khomeini Hospital, Azadegan St, Ahvaz.
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nader Saaki
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd. Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Proportion provided by this source
100
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
Ahvaz Jundishapur University Of Medical Sciences
Full name of responsible person
Amir Abbasnezhad
Position
Ph.D candidate of nutrition
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd. Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3373 8319
Fax
Email
abbasnezhad91@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Judishapur University of Medical Sciences
Full name of responsible person
Reza Amani
Position
Associate Professor of nutrition group
Other areas of specialty/work
Street address
Ahvaz Judishapur University of Medical Sciences, Golestan Blvd. Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3373 8319
Fax
Email
rezaamani@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Siences
Full name of responsible person
Amir Abbasnezhad
Position
Ph.D candidate of nutrition
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd. Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3373 8319
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)