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. 2018 May 10;2018(5):CD012069. doi: 10.1002/14651858.CD012069.pub2

Akhondzadeh 2004.

Methods A 6‐week double‐blind, placebo‐controlled, parallel group trial with 2 interventions:
  1. Methylphenidate + zinc sulfate

  2. Methylphenidate + placebo

Participants Number of participants screened: not stated
Number of participants included: 22
Number of participants followed up: 20
Number of withdrawals: 2
Diagnosis of ADHD: DSM‐IV (subtype: combined (100%))
Age: mean: 7.73 (1.63), range: 5‐11
IQ: > 70
Sex: 12 males, 10 females
Methylphenidate‐naïve: 100%
Ethnicity: Persian
Country: Iran
Setting: outpatient clinic
Comorbidity: not stated
Comedication: not stated
Sociodemographics: not stated
Exclusion criteria
  1. Previously diagnosed with a psychiatric disorder

  2. Mental retardation (IQ < 70)

  3. Clinically significant chronic medical condition, including a past history of cardiovascular disease, organic brain disorder, seizures, current abuse or dependence on drugs within 6 months

  4. Current treatment with psychotropic medications

Interventions Methylphenidate type: not stated
Methylphenidate dosage: 1 mg/kg/day (+ placebo: sucrose, 55 mg)
Administration schedule: twice daily, 7 am and 3 pm
Duration of each medication condition: 6 weeks
Treatment compliance: not stated
Outcomes Systematically recorded throughout the study and were assessed using a checklist administered by a resident of psychiatry on days 7, 14, 21, 28 and 42
Non‐serious adverse events:
  1. Anxiety: 3

  2. Decreased appetite: 7

  3. Difficulty falling asleep: 6

  4. Abdominal pain: 4

  5. Nausea: 3

  6. Headache: 9

  7. Metallic taste: 0

Notes Sample calculation: not stated
Any withdrawals due to adverse events: none
Ethics approval: not explicitly stated but inferred: informed consent (parent and children) was received before the administration of any study procedure or dispensing of study medication in accordance with the ethical standards of the investigative site's institutional review board and with the Helsinki Declaration of 1975, as revised in 2000
Funding/vested interests/authors' affiliations: not stated
Key conclusions from study authors: this double‐blind, placebo‐controlled study demonstrated that zinc as a supplementary medication might be beneficial in the treat‐ ment of children with ADHD. However, further investigations and different doses of zinc are required to replicate these findings in children with ADHD.
Comments from the study authors: the limitations of the present study, including lack of a full placebo group, using only a moderate dose of methylphenidate, the small number of participants, short period of follow‐up and lack of plasma zinc concentration should be considered so further research in this area is needed
Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: no