Investigating the effect of Folic acid on reducing appetite caused by the use of methylphenidate in children with attention deficit hyperactivity disorder
Aim of the study: Investigating the effect of Folic acid on reducing appetite caused by the use of methylphenidate in children with attention deficit hyperactivity disorder
Key Inclusion Criteria: patients aged between 6 to 12 years old; ADHD diagnosing based on DSMIV; clinical need to treat with methylphenidate
Key Exclusion Criteria: patients with epilepsy and diabetes; cardiovascular disorder; history of severe side effect with the previous use of methylphenidate
Study Population: Seventy patients aged between 6 to 12 years old suffered from ADHD under treatment with methylphenidate. Random division: 35 patients in intervention group, 35 patients in control group.
Study Intervention: in interventiol group: receiving Folic acid (5mg/day) with of methylphenidate (average1 mg/kg) for 8 weeks, in control group: receiving methylphenidate (average1 mg/kg) with placebo for 8 weeks
Primary outcome: Evaluation of appetite at the beginning of the study, after 2, 4 and 8 weeks with questionnaire and examination of height and weight
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016040927304N1
Registration date:2016-04-21, 1395/02/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-21, 1395/02/02
Registrant information
Name
Ghazal Salehi vanani
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3554 1578
Email address
salehivanani.gh@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2015-10-22, 1394/07/30
Expected recruitment end date
2016-06-20, 1395/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Folic acid on reducing appetite caused by the use of methylphenidate in children with attention deficit hyperactivity disorder
Public title
Effect of Folic acid on reducing appetite caused by the use of methylphenidate in children with attention deficit hyperactivity disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients aged between 6 to 12 years old; ADHD diagnosing based on DSMIV; clinical need to treat with methylphenidate; not receiving other pharmacological intervention 2 weeks before the intervention; completing consent form; ability to refer for follow up visits
Exclusion criteria: patients with epilepsy and diabetes; cardiovascular disorder; disorder or using drugs that elevate sympathic system activity like Pheochromocytoma; using Pseudoephedrine; psychosis in patient or in their parents; bipolar disorder; using any drugs and supplements which affect weight; low birth weight; history of prematurity; comorbid tourette, celiac, phenylketonuria, autism, mental retardation syndrome; failure to thrive approved in advance by pediatricians; history of severe side effect with the previous use of methylphenidate; mother drug user ;reduced appetite before the study; minor thalassemia
Age
From 6 years old to 12 years old
Gender
Both
Phase
2-3
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
Ahvaz Jundishapur University of Medical Sciences
Street address
Vice Chancellor for Research and Technology Development, universal city, Ahvaz
City
Ahvaz
Postal code
6135715794
Approval date
2015-10-17, 1394/07/25
Ethics committee reference number
IR.AJMS.REC.1394.416
Health conditions studied
1
Description of health condition studied
Attention Deficit Hyperactivity Disorder (ADHD)
ICD-10 code
F90.0
ICD-10 code description
Disturbance of activity and attention
Primary outcomes
1
Description
Appetite score
Timepoint
0-2-4-6-8 weeks
Method of measurement
questionnaire
Secondary outcomes
1
Description
The weight change
Timepoint
0-2-4-6-8 weeks
Method of measurement
examination of weight
2
Description
The BMI change
Timepoint
0-2-4-6-8 weeks
Method of measurement
examination of weight and height and standard formula
Intervention groups
1
Description
Interventional group: receiving Folic acid (5mg/day) with of methylphenidate (average1 mg/kg) for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: receiving methylphenidate (average1 mg/kg) with placebo for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Child and Adolescents Psychiatric Clinic, Golestan Hospital
Full name of responsible person
Street address
Golestan hospital, Ahvaz, Khuzestan
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Nader Saki
Street address
Vice Chancellor for Research and Technology Development, universal city, Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?