The aim of this study is to determine the effect of folic acid on the endothelial dysfunction in children with type 1 diabetes. The study is double blind, placebo-controlled crossover trial. Sixty patients with type 1 diabetes selected and divided in two groups. Each group has 30 people. Folic acid (5 mg) and placebo (produced in Amin Daru factory) was given to each group for 2 months and following a 2 week wash out period cross over was done. Blood samples for endothelial markers (ICAM, VCAM, vWf), lipid profile, FBS and serum folate level will be drawn at 0, 8, 10 and 18 weeks in all of the subjects (before and after drug and placebo).Urine samples are taken for microalbuminuria. Analysis of data will be done by SPSS using ANOVA and t Test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811033138N1
Registration date:2010-05-23, 1389/03/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-05-23, 1389/03/02
Registrant information
Name
Mohammad Hassan Moaddab
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1223 1263
Email address
moadab@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellery of Researche,Isfahan University of Medical Sciences
Expected recruitment start date
2009-09-23, 1388/07/01
Expected recruitment end date
2010-06-21, 1389/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Folic Acid on the Endothelial Dysfunction in Children with Diabetes Type 1
Public title
Endothelial Dysfunction in Diabetes Mellitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:1) Children with diabetes type 1 with at least 1 yr duration. 2) Age >5 yr and < 20 yr. 3) No other systemic diseases. 4) No drug use other than insulin. 5) No hypoglycemia or ketosis during past 48 hr. 6) No smoking. 7) No pregnancy.
Exclusion criteria: Uncooperae patient
Age
From 5 years old to 20 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellery of research
Street address
Isfahan University of Mmedical Sciences
City
Isfahan
Postal code
Approval date
2009-06-09, 1388/03/19
Ethics committee reference number
187150
Health conditions studied
1
Description of health condition studied
Diabetes Melitus Type 1
ICD-10 code
E10
ICD-10 code description
Insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Endothelial dysfunction
Timepoint
0, 8, 10, 18 weeks
Method of measurement
ICAM, VCAM, vwf
Secondary outcomes
1
Description
Lipid profile
Timepoint
0, 8, 10, 18 weeks
Method of measurement
Trigliceride, cholesterol, HDL-c, LDL-c
2
Description
Microalbuminuria
Timepoint
0, 8, 10, 18 weeks
Method of measurement
Urine microalbumin and creatinine
Intervention groups
1
Description
Folic acid, 5mg/day, two perod of 2 months, cross over
Category
Treatment - Drugs
2
Description
Placebo, 2 period of 2 months, cross over
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric Endocrinology OPD
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chanceller of Research,Isfahan University of Medical sciences
Full name of responsible person
Dr Seyed Mohammad Hashemi
Street address
Isfahan University of Medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chanceller of Research,Isfahan 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
Isfahan University of Medical Sciencesisfahan
Full name of responsible person
Mohammad Hassan Moaddab,MD
Position
Pediatric Endocrinologist
Other areas of specialty/work
Street address
Isfahan University of Medical Sciencesisfahan
City
Isfahan
Postal code
Phone
+98 31 1223 1263
Fax
Email
moadab@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mohammad Hassan Moaddab,MD
Position
Pediatric Endocrinologist
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1223 1263
Fax
Email
moadab@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mohammad Hassan Moaddab,MD
Position
Pediatric Endocrinologist
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)