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 |
| Protocol serial number | Roozbeh Trial |
| Sponsor | Tehran University of Medical Sciences (Iran) |
| Funder | Tehran University of Medical Sciences (Iran) |
- 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
Scientific
Roozbeh Psychiatric Hospital
Tehran University of Medical Sciences
South Kargar Street
Tehran
13337
Iran
| s.akhond@sina.tums.ac.ir |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | Zinc ADHD Trial |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Methylphenidate, zinc sulphate |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/10/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 44 |
| Key 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. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2002 |
| Date of final enrolment | 01/10/2003 |
Locations
Countries of recruitment
- Iran
Study participating centre
Roozbeh Psychiatric Hospital
Tehran
13337
Iran
13337
Iran
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
