The purpose of this project is to determine the effect of administering different amounts of vitamin D to the needs of children with inflammatory bowel disease to this vitamin, which is done randomly, double blind and multi-center, including all government centers that have clients with this disease. This study was performed in Phase III clinical trials on 30 patients in each group, including patients receiving 800 units of vitamin D per day and other group that receiving 3,000 units of vitamin per day in 6 weeks. The main inclusion criteria are baby's infant's bowel inflammatory bowel disease include Crohn's disease or colitis and patient satisfaction. The main exclusion criterion is the lack of proper testing of the patient, as well as the patient's dissatisfaction with the continuation or death of the patient. Initially, the symptoms and severity of the disease were measured by a questionnaire. During and after the treatment, the amount of vitamin D, serum albumin, calcium and phosphate ions was measured in each exact test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011075123N1
Registration date:2017-07-15, 1396/04/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-15, 1396/04/24
Registrant information
Name
Hamidreza Kianifar
Name of organization / entity
Mashahd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1801 2469
Email address
kianifarhr@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of different levels of vitamin D on the supply of children with inflammatory bowel disease
Public title
The effect of vitamin D on the improvement of abdominal pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Inflammatory bowel disease; patient and patient's parents satisfaction
Exclusion criteria: Failure to perform tests in all project stages; taking the supplementation incorrectly; patient dissatisfaction for continuation of the project
Age
From 1 year old to 24 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Daneshgah Street Qureshi building
City
Mashhad
Postal code
Approval date
2016-11-09, 1395/08/19
Ethics committee reference number
IR.MUMS.fm.REC.1395.232
Health conditions studied
1
Description of health condition studied
Inflammatory Bowel Disease
ICD-10 code
(K50-K52)
ICD-10 code description
Noninfective inflammatory bowel disease
Primary outcomes
1
Description
Clinical Symptoms
Timepoint
Befor the trial
Method of measurement
Questionnaire
2
Description
Severity of disease
Timepoint
Befor the trial
Method of measurement
Questionnaire
Secondary outcomes
1
Description
VIT D
Timepoint
After the trial
Method of measurement
HPLC
2
Description
Ca & P
Timepoint
After the trial
Method of measurement
Enzymatic
3
Description
Level of serumic Albmin
Timepoint
After the trial
Method of measurement
Enzymatic
4
Description
Level of serumic Feritin
Timepoint
After the trial
Method of measurement
chemoluminescence
Intervention groups
1
Description
In the first intervention group, daily dose of 800 units of vitamin D is administered for 6 weeks. because the availability of 50,000 single pearls on the market, aggregate daily doses may be given as one pearl every few weeks.
Category
Treatment - Drugs
2
Description
In the second intervention group, daily dose of 3000 units of vitamin D is administered for 6 weeks. because the availability of 50,000 single pearls on the market, aggregate daily doses may be given as one pearl every few weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Dr.Mohsen Tafaghodi
Street address
Daneshgah Ave,Ghoreishi, Mashhad
City
Mshhad
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, Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Majid Khademian
Position
Fellows in Training
Other areas of specialty/work
Street address
Department of Pediatrics, Hospital Ghaem, Ahmadabad streets, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3801 2753
Fax
Email
khademianm941@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamidreza Kianifar
Position
Full Professor
Other areas of specialty/work
Street address
Department of Peditrics,Ghaem Hospital , Ahmadabad streets, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3801 2753
Fax
Email
KianifarHR@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Majid Khademian
Position
Other areas of specialty/work
Street address
City
Mashhad
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)