In this study , 66 patients with irritable bowel syndrome,
attending counseling and treatment center for gastrointestinal diseases,
with the inclusion criteria randomly assig to two groups.
The first group take one vitamin D3 (50000
IU) weekly for 2 months, in addition to dietary recommendations.
The second group , along with dietary recommendations take placebo.
Serum level of 25(OH)D and clinical signs of disease (abdominal pain, bloating , diarrhea and constipation ) , and quality of life (questionnaire) are measured before the treatment and after its completion. The effect of vitamin D3 supplementation is compared to placebo in order to investigate the effect of vitamin D3 in improving the symptoms of irritable bowel syndrome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201402234010N11
Registration date:2014-04-04, 1393/01/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-04-04, 1393/01/15
Registrant information
Name
Azita Hekmatdoost
Name of organization / entity
Shahid Beheshti University of Medical Sciences, National Institute of Nutrition Research
Country
Iran (Islamic Republic of)
Phone
+98 21 2293 0824
Email address
hekmat@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
There is no funding support for this study.
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2013-07-11, 1392/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of The Effects of vitamin D3 supplementation on Irritable bowel syndrome symptoms
Public title
Evaluation of the Effects of vitamin D3 supplementation on Irritable bowel syndrome symptoms.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 18 to 65 years old; serum level of 25(OH)D under 30 ng/ml; evidence of having irritable bowel syndrome using Rome III Criteria; not having Vitamin D supplementation since one year ago; not having a history of alcohol drink; not suffering from other organic diseases of the intestine, bowel surgery, breast; cancer, severe mental illness; not pregnant, breastfeeding and professional sports; not taking Non-steroidal anti-inflammatory drug ( NSAIDs), laxatives, nicotine, artificial sweeteners, antibiotics, immunomodulators or repression, intestinal bleeding, drugs, fish oils and digestive movements modifier.
Exclusion criteria: their unwillingness to continue the study for any reason; pregnancy.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Nutrition and Food Technology Research Institute (NNFTRI)
Intervention 1:
In intervention group:
- oral vitamin D3 (50000IU), one per week, for 2 months.
classifying Intervention:
drug intervention using drug.
Category
Treatment - Drugs
2
Description
Intervention 2:
In placebo group:
capsules containing rice flour (placebo), one per week for 2 months.
- classifying intervention: intervention with placebo.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastrointestinal Clinic
Full name of responsible person
Dr Azita Hekmatdoost
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Nutrition and Food Technology Research Institute (NNFTRI)
Full name of responsible person
Dr. Majid Haji Faraji
Street address
#7, Shahrak Gharb, Farahzadi Blvd, Hafezieh St (Arghavan Gharbi), No 7.
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 Research Institute (NNFTRI)
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
National Nutrition and Food Technology Research Institute (NNFTRI)
Full name of responsible person
Dr. Azita Hekmatdoost
Position
Associate Prof
Other areas of specialty/work
Street address
#7, Shahrak Gharb, Farahzadi Blvd, Arghavan Gharbi, Research Institute of Nutrition and Food Technology
City
Tehran
Postal code
Phone
+98 21 2235 7484
Fax
Email
a_hekmat2000@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
National Nutrition and Food Technology Research Institute (NNFTRI)
Full name of responsible person
Dr. Azita Hekmatdoost
Position
Associate Prof
Other areas of specialty/work
Street address
Gharb Shahrak, Farahzadi Blvd, ArghavanGharbi, Research Institute of Nutrition and Food Technology.
City
tehran
Postal code
Phone
+98 21 2235 7484
Fax
Email
a_hekmat2000@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)