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Zinc sulfate as an adjunct to methylphenidate for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children: a double blind and randomised trial
ISRCTN ISRCTN64132371
DOI 10.1186/ISRCTN64132371
ClinicalTrials.gov identifier
EudraCT number
Public title Zinc sulfate as an adjunct to methylphenidate for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children: a double blind and randomised trial
Scientific title
Acronym Zinc ADHD Trial
Serial number at source Roozbeh Trial
Study hypothesis Not provided at time of registration
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment Iran
Disease/condition/study domain Attention Deficit Hyperactivity Disorder (ADHD)
Participants - inclusion criteria Subjects were 44 outpatient children (26 boys and 18 girls) between the ages of 5 - 11 (mean ± SD was 7.88 ± 1.67) who clearly met the Diagnostic and Statistical Manual of Mental Disorders, Fourth edition (DSM IV) diagnostic criteria for attention-deficit hyperactivity disorder.
Participants - exclusion criteria Not provided at time of registration
Anticipated start date 01/01/2002
Anticipated end date 01/10/2003
Status of trial Completed
Patient information material
Target number of participants 44
Interventions Patients were randomised to methylphenidate 1 mg/kg/day + zinc sulfate 55 mg/day (with approximately 15 mg zinc element) (group 1) and methylphenidate 1 mg/kg/day + placebo (sucrose 55 mg) (group 2) for a 6 week double blind clinical trial. The principal measure of the outcome was the Teacher and Parent ADHD Rating Scale. Patients were assessed by a child psychiatrist at baseline, 14, 28 and 42 days after the medication started.
Primary outcome measure(s) Not provided at time of registration
Secondary outcome measure(s) Not provided at time of registration
Sources of funding Tehran University of Medical Sciences (Iran)
Trial website
Publications Results in: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=15070418
Contact name Dr  Shahin  Akhondzadeh
  Address Roozbeh Psychiatric Hospital
Tehran University of Medical Sciences
South Kargar Street
  City/town Tehran
  Zip/Postcode 13337
  Country Iran
  Email s.akhond@sina.tums.ac.ir
Sponsor Tehran University of Medical Sciences (Iran)
  Address South Kargar Street
  City/town Tehran
  Zip/Postcode 13337
  Country Iran
  Email s.akhond@sina.tums.ac.ir
Date applied 22/02/2004
Last edited 24/08/2007
Date ISRCTN assigned 23/02/2004
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