ArticleBMC psychiatry2011
Systematic review of safety and tolerability of a complex micronutrient formula used in mental health.
Article in BMC psychiatry, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pooled it
- Micronutrients for Attention-Deficit/Hyperactivity Disorder in Youths: A Placebo-Controlled Randomized Clinical Trial.Journal of the American Academy of Child and Adolescent Psychiatry · 2022Trial
- Vitamin-mineral treatment improves aggression and emotional regulation in children with ADHD: a fully blinded, randomized, placebo-controlled trial.Journal of child psychology and psychiatry, and allied disciplines · 2018Trial
- Nutritional and safety outcomes from an open-label micronutrient intervention for pediatric bipolar spectrum disorders.Journal of child and adolescent psychopharmacology · 2013Trial
- Investigation of a broad-spectrum micronutrient formulation as a possible precipitant of pharmacokinetic micronutrient-drug interactions.British journal of clinical pharmacology · 2025Article
- Annual Research Review: Micronutrients and their role in the treatment of paediatric mental illness.Journal of child psychology and psychiatry, and allied disciplines · 2025Review
- Dr. Johnstone et al. Reply to Dr. Elmrayed.Journal of the American Academy of Child and Adolescent Psychiatry · 2023Article
- Protocol for a randomised placebo-controlled trial investigating the efficacy and safety of a vitamin-mineral formula targeting dysregulated emotions in teenagers: The balancing emotions of adolescents with micronutrients (BEAM) study.Contemporary clinical trials communications · 2022Article
- Study Protocol for a Randomized Double Blind, Treatment Control Trial Comparing the Efficacy of a Micronutrient Formula to a Single Vitamin Supplement in the Treatment of Premenstrual Syndrome.Medicines (Basel, Switzerland) · 2016Article
- Psychosis Resulting From Herbs Rather Than Nutrients.The primary care companion for CNS disorders · 2016Article
- 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 · 2015Article
- Micronutrient treatment for children with emotional and behavioral dysregulation: a case series.Journal of medical case reports · 2015Article
- Broad-spectrum micronutrient treatment for attention-deficit/hyperactivity disorder: rationale and evidence to date.CNS drugs · 2014Review
- Efficacy and cost of micronutrient treatment of childhood psychosis.BMJ case reports · 2012Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTheoretically, consumption of complex, multinutrient formulations of vitamins and minerals should be safe, as most preparations contain primarily the nutrients that have been in the human diet for millennia, and at safe levels as defined by the Dietary Reference Intakes. However, the safety profile of commercial formulae may differ from foods because of the amounts and combinations of nutrients they contain. As these complex formulae are being studied and used clinically with increasing frequency, there is a need for direct evaluation of safety and tolerability.
methodsAll known safety and tolerability data collected on one complex nutrient formula was compiled and evaluated.
resultsData were assembled from all the known published and unpublished studies for the complex formula with the largest amount of published research in mental health. Biological safety data from 144 children and adults were available from six sources: there were no occurrences of clinically meaningful negative outcomes/effects or abnormal blood tests that could be attributed to toxicity. Adverse event (AE) information from 157 children and adults was available from six studies employing the current version of this formula, and only minor, transitory reports of headache and nausea emerged. Only one of the studies permitted a direct comparison between micronutrient treatment and medication: none of the 88 pediatric and adult participants had any clinically meaningful abnormal laboratory values, but tolerability data in the group treated with micronutrients revealed significantly fewer AEs and less weight gain.
conclusionsThis compilation of safety and tolerability data is reassuring with respect to the broad spectrum approach that employs complex nutrient formulae as a primary treatment.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.