Contact information
Type
Scientific
Primary contact
Dr Shahin Akhondzadeh
ORCID ID
Contact details
Roozbeh Psychiatric Hospital
Tehran University of Medical Sciences
South Kargar Street
Tehran
13337
Iran
s.akhond@sina.tums.ac.ir
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Roozbeh Trial
Study information
Scientific title
Acronym
Zinc ADHD Trial
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Attention Deficit Hyperactivity Disorder (ADHD)
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Methylphenidate, zinc sulphate
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2002
Overall trial end date
01/10/2003
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
44
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2002
Recruitment end date
01/10/2003
Locations
Countries of recruitment
Iran
Trial participating centre
Roozbeh Psychiatric Hospital
Tehran
13337
Iran
Sponsor information
Organisation
Tehran University of Medical Sciences (Iran)
Sponsor details
South Kargar Street
Tehran
13337
Iran
s.akhond@sina.tums.ac.ir
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Tehran University of Medical Sciences (Iran)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=15070418
Publication citations
-
Results
Akhondzadeh S, Mohammadi MR, Khademi M, Zinc sulfate as an adjunct to methylphenidate for the treatment of attention deficit hyperactivity disorder in children: a double blind and randomized trial [ISRCTN64132371]., BMC Psychiatry, 2004, 4, 9, doi: 10.1186/1471-244X-4-9.