To determine the effect of folic acid on homocysteine levels and plasma insulin in children and adolescents with weight gain and obesity, single- center, phase 3 trial 2) Participant: Inclusion criteria: children and adolescents with a body mass index above the eighty-fifth percent for age and sex. Exclusion criteria: obesity due to genetic syndrome, obesity, endocrine disorders such as hypothyroidism and Cushing; children who are on a diet to lose weight, catching any diseases that affect the homocysteine levels such as kidney and liver disease, children who are using supplements 3) Population: 60 patients divide in case and control 4 ) Interventions : intervention group will be used of folic acid 1 mg daily in first group and the second group received 5 mg daily and the control group do not take drugs 5) Comparison: Six months 6) Outcome: reduction of independent risk factor for cardiovascular
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014020116435N1
Registration date:2014-05-23, 1393/03/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-05-23, 1393/03/02
Registrant information
Name
Elham Hashemi
Name of organization / entity
Pediatric endocrinology
Country
Iran (Islamic Republic of)
Phone
+98 38 1222 0016
Email address
hashemi_elham@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of folic acid on homocysteine and plasma insulin levels in weight gain and obesity in children and adolescents
Public title
The effect of folic acid on homocysteine and plasma insulin levels in weight gain and obesity in children and adolescents
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: children and adolescents with a body mass index above the eighty-fifth percent for age and sex Exclusion criteria: obesity due to genetic syndrome, obesity, endocrine disorders such as hypothyroidism and Cushing; children who are on a diet to lose weight, catching any diseases that affect the hemocysteine levels such as kidney and liver disease, children who are using supplements
Age
From 5 years old to 12 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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Shahrekord, Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
Approval date
2012-02-26, 1390/12/07
Ethics committee reference number
12-11-90
Health conditions studied
1
Description of health condition studied
obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
Decrease of cardiovascular factor
Timepoint
6 months latter
Method of measurement
sampling
Secondary outcomes
empty
Intervention groups
1
Description
The first group acid folic tablet 1mg receive.
Category
Treatment - Drugs
2
Description
The second group acid folic tablet 5mg daily receive.
Category
Treatment - Drugs
3
Description
Third group served as controls and do not take drugs.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric Endocrinology Clinic of Shahrekord
Full name of responsible person
Elham Hashemi
Street address
Shahrekord , Shahrekord University of Medical Sciences
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Shahrekord University of Medical Sciences
Full name of responsible person
Vice chancellor for research of Shahrekord University of Medical Sciences
Street address
Shahrekord, Shahrekord University of Medical Sciences
City
Shahrekord
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 of Shahrekord 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Elham Hashemi
Position
Pediatric Endocrinologist, Assistant Professor
Other areas of specialty/work
Street address
Shahrekord, Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
Phone
+98 38 1333 5652
Fax
Email
hashemi_elham@skums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Elham Hashemi
Position
Pediatric Endocrinologist, Assistant Professor
Other areas of specialty/work
Street address
Shahrekord, Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
Phone
00
Fax
Email
hashemi_elham@skums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)