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Clinically Significant Symptom Reduction in Children with Attention-Deficit/Hyperactivity Disorder Treated with Micronutrients: An Open-Label Reversal Design Study.
J Child Adolesc Psychopharmacol 2015; 25(10):783-98JC

Abstract

OBJECTIVE

The purpose of this study was to investigate the clinical effect and safety of a broad spectrum, 36 ingredient micronutrient (vitamins and minerals) in treating children with attention-deficit/hyperactivity disorder (ADHD).

METHODS

This open-label, on-off-on-off (reversal design) study followed 14 participants (8-12 years of age) with ADHD, diagnosed using standardized instruments, for 6 months with no dropouts. Following baseline assessment, including hematology and biochemistry screening, participants began an 8 week treatment phase with micronutrients titrated up to maximum dose (15 capsules/day). Treatment was withdrawn for 4 weeks, reinstated for a further 8 weeks, and then withdrawn for 4 weeks. Primary outcomes included the Conners' Parent Rating Scale, the Clinical Global Impressions Scale (CGI), and the Strengths and Difficulties Questionnaire - Parent version (SDQ). Secondary outcomes were mood and global functioning.

RESULTS

Modified Brinley plots revealed a reduction in ADHD symptoms, improved mood, and improved overall functioning during intervention phases, and deterioration in ADHD symptoms, mood, and overall functioning during the withdrawal phases. Reliable change analyses, Cohen's d and percent superiority effect sizes, 95% confidence intervals and t tests confirmed clinically and statistically significant change between the intervention and withdrawal phases, with large effect sizes observed pre- to post-exposure of micronutrients (d = 1.2-2.2) on ADHD symptoms during intervention phases. Seventy-one percent of participants showed at least a 30% decrease in ADHD symptoms by the end of the second treatment phase, and 79% were identified as "much improved" or "very much improved" at the end of the second phase (5 months) based on the clinician-rated CGI when considering functioning generally. The SDQ showed that these benefits occurred across other areas of functioning including emotional symptoms, conduct problems, and prosocial behaviours. The children's self-reports confirmed the improvements. Excellent adherence to treatment occurred throughout, side effects were mild and transitory, and no safety issues were identified through blood analyses.

CONCLUSIONS

This study demonstrates the clinical benefit, feasibility, and safety of broad-spectrum micronutrients in the treatment of childhood ADHD. Replications utilizing double-blind placebo-controlled studies are warranted. Trial is registered with the Australia and New Zealand Clinical Trial Registry: ACTRN12612000645853.

Authors+Show Affiliations

1 Department of Psychology, University of Canterbury , Christchurch, New Zealand .1 Department of Psychology, University of Canterbury , Christchurch, New Zealand .1 Department of Psychology, University of Canterbury , Christchurch, New Zealand .2 Departments of Neurology and Psychiatry, Oregon Health & Science University , Portland, Oregon.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

26682999

Citation

Gordon, Heather A., et al. "Clinically Significant Symptom Reduction in Children With Attention-Deficit/Hyperactivity Disorder Treated With Micronutrients: an Open-Label Reversal Design Study." Journal of Child and Adolescent Psychopharmacology, vol. 25, no. 10, 2015, pp. 783-98.
Gordon HA, Rucklidge JJ, Blampied NM, et al. Clinically Significant Symptom Reduction in Children with Attention-Deficit/Hyperactivity Disorder Treated with Micronutrients: An Open-Label Reversal Design Study. J Child Adolesc Psychopharmacol. 2015;25(10):783-98.
Gordon, H. A., Rucklidge, J. J., Blampied, N. M., & Johnstone, J. M. (2015). Clinically Significant Symptom Reduction in Children with Attention-Deficit/Hyperactivity Disorder Treated with Micronutrients: An Open-Label Reversal Design Study. Journal of Child and Adolescent Psychopharmacology, 25(10), pp. 783-98. doi:10.1089/cap.2015.0105.
Gordon HA, et al. Clinically Significant Symptom Reduction in Children With Attention-Deficit/Hyperactivity Disorder Treated With Micronutrients: an Open-Label Reversal Design Study. J Child Adolesc Psychopharmacol. 2015;25(10):783-98. PubMed PMID: 26682999.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clinically Significant Symptom Reduction in Children with Attention-Deficit/Hyperactivity Disorder Treated with Micronutrients: An Open-Label Reversal Design Study. AU - Gordon,Heather A, AU - Rucklidge,Julia J, AU - Blampied,Neville M, AU - Johnstone,Jeanette M, PY - 2015/12/20/entrez PY - 2015/12/20/pubmed PY - 2016/10/7/medline SP - 783 EP - 98 JF - Journal of child and adolescent psychopharmacology JO - J Child Adolesc Psychopharmacol VL - 25 IS - 10 N2 - OBJECTIVE: The purpose of this study was to investigate the clinical effect and safety of a broad spectrum, 36 ingredient micronutrient (vitamins and minerals) in treating children with attention-deficit/hyperactivity disorder (ADHD). METHODS: This open-label, on-off-on-off (reversal design) study followed 14 participants (8-12 years of age) with ADHD, diagnosed using standardized instruments, for 6 months with no dropouts. Following baseline assessment, including hematology and biochemistry screening, participants began an 8 week treatment phase with micronutrients titrated up to maximum dose (15 capsules/day). Treatment was withdrawn for 4 weeks, reinstated for a further 8 weeks, and then withdrawn for 4 weeks. Primary outcomes included the Conners' Parent Rating Scale, the Clinical Global Impressions Scale (CGI), and the Strengths and Difficulties Questionnaire - Parent version (SDQ). Secondary outcomes were mood and global functioning. RESULTS: Modified Brinley plots revealed a reduction in ADHD symptoms, improved mood, and improved overall functioning during intervention phases, and deterioration in ADHD symptoms, mood, and overall functioning during the withdrawal phases. Reliable change analyses, Cohen's d and percent superiority effect sizes, 95% confidence intervals and t tests confirmed clinically and statistically significant change between the intervention and withdrawal phases, with large effect sizes observed pre- to post-exposure of micronutrients (d = 1.2-2.2) on ADHD symptoms during intervention phases. Seventy-one percent of participants showed at least a 30% decrease in ADHD symptoms by the end of the second treatment phase, and 79% were identified as "much improved" or "very much improved" at the end of the second phase (5 months) based on the clinician-rated CGI when considering functioning generally. The SDQ showed that these benefits occurred across other areas of functioning including emotional symptoms, conduct problems, and prosocial behaviours. The children's self-reports confirmed the improvements. Excellent adherence to treatment occurred throughout, side effects were mild and transitory, and no safety issues were identified through blood analyses. CONCLUSIONS: This study demonstrates the clinical benefit, feasibility, and safety of broad-spectrum micronutrients in the treatment of childhood ADHD. Replications utilizing double-blind placebo-controlled studies are warranted. Trial is registered with the Australia and New Zealand Clinical Trial Registry: ACTRN12612000645853. SN - 1557-8992 UR - https://www.unboundmedicine.com/medline/citation/26682999/full_citation L2 - https://www.liebertpub.com/doi/full/10.1089/cap.2015.0105?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -