Condition category
Mental and Behavioural Disorders
Date applied
22/02/2004
Date assigned
23/02/2004
Last edited
24/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

Additional files

Editorial Notes