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 https://doi.org/10.1186/ISRCTN64132371
Secondary identifying numbers Roozbeh Trial
Submission date
22/02/2004
Registration date
23/02/2004
Last edited
24/08/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Shahin Akhondzadeh
Scientific

Roozbeh Psychiatric Hospital
Tehran University of Medical Sciences
South Kargar Street
Tehran
13337
Iran

Email s.akhond@sina.tums.ac.ir

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymZinc ADHD Trial
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedAttention Deficit Hyperactivity Disorder (ADHD)
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Methylphenidate, zinc sulphate
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2002
Completion date01/10/2003

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants44
Key inclusion criteriaSubjects 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.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/2002
Date of final enrolment01/10/2003

Locations

Countries of recruitment

  • Iran

Study participating centre

Roozbeh Psychiatric Hospital
Tehran
13337
Iran

Sponsor information

Tehran University of Medical Sciences (Iran)
Hospital/treatment centre

South Kargar Street
Tehran
13337
Iran

Email s.akhond@sina.tums.ac.ir
ROR logo "ROR" https://ror.org/01c4pz451

Funders

Funder type

Hospital/treatment centre

Tehran University of Medical Sciences (Iran)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 08/04/2004 Yes No