Clinical trial of efficacy evaluation of Ritalin alone and Ritalin with supplement of ferrous sulfate on improvement of hyperactivity and inattention symptoms of non-iron deficient children with attention-deficit/hyperactivity disorder (ADHD)
This study will be done to answer this question that whether or not Ritalin with supplement of ferrous sulfate treatment is more efficient than Ritalin alone in reduction of hyperactivity and inattention symptoms of children with attention-deficit/hyperactivity disorder (ADHD) and without iron deficiency. In a single blind clinical trial, sixty 6-11 year old children with ADHD and without iron deficiency (serum hemoglobin, iron and ferritin levels in normal limits) who would be referred to Pediatric Neurology Clinic of Shahid Sadoughi Hospital, Yazd, Iran will be distributed randomly into two groups. In group I, 20 mg/day of Ritalin and in group II, 20 mg/day of Ritalin and 2mg/kg/day of ferrous sulfate will be given. The drugs will be continued for three months and the children will be followed up monthly for three consecutive months. Primary outcomes include ADHD diagnostic rating scale and the parent Conner rating scales that will be compared before and after three months of treatment. Secondary outcomes include more than 50% of reduction in ADHD diagnostic rating scale and clinical side effects. The trial uses computer generated equal simple randomization by random numbers and data collectors, outcome assessors and data analysts are kept blinded to the allocation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201512262639N17
Registration date:2016-04-16, 1395/01/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-16, 1395/01/28
Registrant information
Name
Razieh Fallah
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Country
Iran (Islamic Republic of)
Phone
+98 35 3822 4000
Email address
fallah@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Expected recruitment start date
2015-04-23, 1394/02/03
Expected recruitment end date
2016-03-10, 1394/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of efficacy evaluation of Ritalin alone and Ritalin with supplement of ferrous sulfate on improvement of hyperactivity and inattention symptoms of non-iron deficient children with attention-deficit/hyperactivity disorder (ADHD)
Public title
Evaluation of efficacy of Ritalin and ferrous sulfate in non-iron deficient children with attention-deficit/hyperactivity disorder (ADHD)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age range of 6-11 years; having ADHD based DSM-IV criteria; having at least score of 20 in ADHD diagnostic rating scale via parent interview; No iron deficiency (serum hemoglobin, iron and ferritin levels in normal limits); Not receiving iron combinations within the past two months; No use of any ADHD therapy
Exclusion criteria: Acute or chronic medical disorders; epilepsy; tic; severe birth asphyxia; severe neonatal jaundice; vision problems; hearing disorders; other psychiatric disorders; irregular drugs usage; discontinuation of iron usage for more than one week
Age
From 6 years old to 11 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Street address
Central building of university, Bahonar square
City
Yazd
Postal code
Approval date
2015-03-17, 1393/12/26
Ethics committee reference number
۱۷/۱/۱۷۷۶۲/ پ
Health conditions studied
1
Description of health condition studied
Attention-deficit/hyperactivity disorder
ICD-10 code
F90.0
ICD-10 code description
Disturbance of activity and attention
Primary outcomes
1
Description
ADHD diagnostic rating scale
Timepoint
Before and three months after treatment
Method of measurement
Parent interview
2
Description
Parent Conner rating scales
Timepoint
Before and three months after treatment
Method of measurement
Parent interview
Secondary outcomes
1
Description
Efficacy in more than 50% of reduction in ADHD diagnostic rating scale
Timepoint
Three months after treatment
Method of measurement
Parent interview
2
Description
Clinical side effects
Timepoint
Monthly until three months after treatment
Method of measurement
Asking from parents
Intervention groups
1
Description
Tablet of 10 mg of Ritalin from Novartis Co, Switzerland in dosage of 2o mg/day divided in two doses and tablet of 50 mg ferrous sulfate from Daroupakhsh Co, Iran in dosage of 2 mg/kg/day single dose for three months
Category
Treatment - Drugs
2
Description
Tablet of ten mg of Ritalin from Novartis Co, Switzerland in dosage of 2o mg/day divided in two dose for three months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric Neurology Clinic of Shahid Sadoughi Hospital,Yazd, Iran