Propose of this randomized double blind placebo controlled clinical trial is to evaluate the effect of Biotin on blood glucose and serum lipid concentration in type 1 diabetic patients, therefore 70 insulin dependent diabetic patients (5-25 years old) with poorly controlled (glaciated hemoglobin >=8%) were recruited and randomly allocated into two groups. In intervention group, Biotin (40 mcg/kg) was administrated in addition to daily insulin regimen for three months. Laboratory tests including fasting blood sugar, hemoglobin A1C and plasma lipids were measured at the baseline and after 3 months of treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110027691N1
Registration date:2011-11-14, 1390/08/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-11-14, 1390/08/23
Registrant information
Name
Mitra Hemmati
Name of organization / entity
Kermanshah Universityof Medical Science and Health Service
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6309
Email address
mitra_hemmati@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology of Kermanshah University of Medical Sciences
Expected recruitment start date
2008-04-01, 1387/01/13
Expected recruitment end date
2009-04-01, 1388/01/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Biotin on blood glucose and plasma lipids in insulin dependent diabetic patients
Public title
The effect of Biotin on blood glucose and plasma lipids in diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: HbA1C more than 8% and history of diabetes type 1 for at least one year; age of 5-25 years old.
Exclusion criteria : history of renal and cardiac disease, seizure, using corticosteroids or anti-convulsive drugs, also history of hypoglycemic attacks or ketoacidosis during past 3 months, and pregnancy.
Age
From 5 years old to 25 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
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 Kermanshah University of Medical Sciences
Street address
Building no. 2, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2008-03-01, 1386/12/11
Ethics committee reference number
87256
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E10
ICD-10 code description
Insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Hg A1C
Timepoint
at the baseline and 3 months after intervention
Method of measurement
labratory test (Nycocard kits)
2
Description
Lipiod profile (cholesterol, triglycerides, low dencity lipoprotein, high dencity lipoprotein)
Timepoint
before intervention and after 3 months
Method of measurement
laberatory method
Secondary outcomes
1
Description
advers effects such as hypoglycemia, no tolerance to biotin
Timepoint
during the intervention
Method of measurement
self monitoring blood sugar by subjects
Intervention groups
1
Description
Intervention group: 40 mcg/kg of Biotin, once daily for 3 months
Category
Treatment - Drugs
2
Description
Control group: placebo once daily for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Mitra Hemmati
Street address
Department of Pediatric, Imam Reza Hospital, Kermanshah University of Medical Sciences
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology of Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafei
Street address
Shahid Beheshti Blvd.
City
Kermanshah
Grant name
هزینه پژوهشی دستیاران
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology of Kermanshah 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
Kermanshah university of medical sciences
Full name of responsible person
Mitra Hemmati
Position
assistant professor
Other areas of specialty/work
Street address
Imam Reza Hospital, Parastar Blvd.
City
Kermanshah
Postal code
6714415334
Phone
+98 83 1427 6309
Fax
+98 83 1427 6355
Email
mitra_hemmati@yahoo.com
Web page address
KUMS.AC.IR
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mitra Hemmati
Position
assistant professor of pediatrics
Other areas of specialty/work
Street address
Department of Pediatric, Imam Reza Hospital, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
6714415334
Phone
+98 83142763019
Fax
+98 83 1427 6355
Email
mitra_hemmati@yahoo.com
Web page address
www.kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mitra Hemmati
Position
assistant professor
Other areas of specialty/work
Street address
Department of Pediatric, Imam Reza Hospital, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
6714415334
Phone
+98 83142763019
Fax
+98 83 1427 6355
Email
mitra_hemmati@yahoo.com
Web page address
www.kums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)