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Zinc sulfate as an adjunct to methylphenidate for the treatment of attention deficit hyperactivity disorder in children: a double blind and randomized trial [ISRCTN64132371].

Abstract

BACKGROUND

Attention-deficit hyperactivity disorder is an early-onset, clinically heterogenous disorder of inattention, hyperactivity, and impulsiveness. The diagnosis and treatment of attention-deficit hyperactivity disorder continues to raise controversy, and, there is also an increase in treatment options. In this 6-week double blind, placebo controlled-trial, we assessed the effects of zinc plus methylphenidate in the treatment of children with attention deficit hyperactivity disorder. To the best of our knowledge, this study is the first double blind and placebo controlled clinical trial assessing the adjunctive role of zinc in ADHD.

METHODS

Our 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 DSM IV diagnostic criteria for attention-deficit hyperactivity disorder and they were randomized 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.

RESULTS

The present study shows the Parent and Teacher Rating Scale scores improved with zinc sulfate over this 6-week, double blind and placebo controlled trial. The behavior of the two treatments was not homogeneous across the time. The difference between the two protocols was significant as indicated by the effect on the group, the between-subjects factor (F = 4.15, d.f. = 1, P = 0.04; F = 4.50, d.f. = 1, P = 0.04 respectively). The difference between the two groups in the frequency of side effects was not significant.

CONCLUSIONS

This double-blind, placebo-controlled study demonstrated that zinc as a supplementary medication might be beneficial in the treatment of children with attention-deficit hyperactivity disorder. However, further investigations and different doses of zinc are required to replicate these findings in children with ADHD.

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  • Authors+Show Affiliations

    ,

    Pychiatric Research Centre, Roozbeh Hospital, Tehran University of Medical Sciences, South Kargar Street, Tehran 13185, Iran. s.akhond@neda.net

    ,

    Source

    BMC psychiatry 4: 2004 Apr 08 pg 9

    MeSH

    Ambulatory Care
    Attention Deficit Disorder with Hyperactivity
    Child
    Child, Preschool
    Double-Blind Method
    Drug Administration Schedule
    Drug Therapy, Combination
    Female
    Humans
    Male
    Methylphenidate
    Placebos
    Psychiatric Status Rating Scales
    Treatment Outcome
    Zinc Sulfate

    Pub Type(s)

    Clinical Trial
    Comparative Study
    Journal Article
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    15070418

    Citation

    Akhondzadeh, Shahin, et al. "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, vol. 4, 2004, p. 9.
    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.
    Akhondzadeh, S., Mohammadi, M. R., & Khademi, M. (2004). 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, 4, p. 9.
    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 Apr 8;4:9. PubMed PMID: 15070418.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Zinc sulfate as an adjunct to methylphenidate for the treatment of attention deficit hyperactivity disorder in children: a double blind and randomized trial [ISRCTN64132371]. AU - Akhondzadeh,Shahin, AU - Mohammadi,Mohammad-Reza, AU - Khademi,Mojgan, Y1 - 2004/04/08/ PY - 2004/01/25/received PY - 2004/04/08/accepted PY - 2004/4/9/pubmed PY - 2004/5/21/medline PY - 2004/4/9/entrez SP - 9 EP - 9 JF - BMC psychiatry JO - BMC Psychiatry VL - 4 N2 - BACKGROUND: Attention-deficit hyperactivity disorder is an early-onset, clinically heterogenous disorder of inattention, hyperactivity, and impulsiveness. The diagnosis and treatment of attention-deficit hyperactivity disorder continues to raise controversy, and, there is also an increase in treatment options. In this 6-week double blind, placebo controlled-trial, we assessed the effects of zinc plus methylphenidate in the treatment of children with attention deficit hyperactivity disorder. To the best of our knowledge, this study is the first double blind and placebo controlled clinical trial assessing the adjunctive role of zinc in ADHD. METHODS: Our 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 DSM IV diagnostic criteria for attention-deficit hyperactivity disorder and they were randomized 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. RESULTS: The present study shows the Parent and Teacher Rating Scale scores improved with zinc sulfate over this 6-week, double blind and placebo controlled trial. The behavior of the two treatments was not homogeneous across the time. The difference between the two protocols was significant as indicated by the effect on the group, the between-subjects factor (F = 4.15, d.f. = 1, P = 0.04; F = 4.50, d.f. = 1, P = 0.04 respectively). The difference between the two groups in the frequency of side effects was not significant. CONCLUSIONS: This double-blind, placebo-controlled study demonstrated that zinc as a supplementary medication might be beneficial in the treatment of children with attention-deficit hyperactivity disorder. However, further investigations and different doses of zinc are required to replicate these findings in children with ADHD. SN - 1471-244X UR - https://www.unboundmedicine.com/medline/citation/15070418/full_citation L2 - https://bmcpsychiatry.biomedcentral.com/articles/10.1186/1471-244X-4-9 DB - PRIME DP - Unbound Medicine ER -