Evidence map›Paper›PMID 22151477›Full record

Trial reportBMC pediatrics2011

Effect of a vitamin/mineral supplement on children and adults with autism.

James B Adams, Tapan Audhya, Sharon McDonough-Means, Robert A Rubin, David Quig, Elizabeth Geis, Eva Gehn, Melissa Loresto, Jessica Mitchell, Sharon Atwood and 2 more

3 registry-linked trialsOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC pediatrics, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 99 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
99citing papers in PubMed, 3 pooled it
7.2field-weighted citation impact, top 2% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT01225198 phase2completednot on this map

New Vitamin/Mineral Supplement for Children and Adults With Autism - National Study

TypeinterventionalSponsorArizona State UniversityRan2008 to 2009Enrolled143ConditionsAutismArmsMulti-Vitamin/Mineral Supplement, Liquid Placebo
NCT04312152 naunknown statusnot on this mapstarted 2019, after this paper: background citation

Randomized, Placebo-controlled, Cross-over, Double-blind Study of a Metabolic Support Therapy With Q10 Ubiquinol and a Multivitamin B and E Complex in Two Cohorts of Patients With Idiopathic and Syndromic Autism (Phelan-McDermid Syndrome)

TypeinterventionalSponsorAntonio PersicoRan2019 to 2023Enrolled200ConditionsAutism Spectrum Disorder, Phelan-McDermid SyndromeArmsQ10 Ubiquinol, Vitamin E, Multi-Vitamin B complex
NCT06623227 naenrolling by invitationnot on this mapstarted 2024, after this paper: background citation

Randomized, Placebo-controlled, Double-blind Study of Increasing Total Antioxidant Capacity with Vitamin E and C in Two Cohorts of Patients with Autism Spectrum Disorders

TypeinterventionalSponsorRinvil RenaldiRan2024 to 2025Enrolled50ConditionsAutism Spectrum DisorderArmsPlacebo, Vitamin E and C
3 · Its place in the literature

Who cites it

99 citing papers in PubMed, 3 syntheses or guidelines pooled it, 294 citations in OpenAlex.

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39 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 3 institutions in 1 country.

James B AdamsAutism/Asperger's Research Program, Arizona State University, Tempe, AZ, USA. jim.adams@asu.edu
Tapan Audhya
Sharon McDonough-Means
Robert A Rubin
David Quig
Elizabeth Geis
Eva Gehn
Melissa Loresto
Jessica Mitchell
Sharon Atwood
Suzanne Barnhouse
Wondra Lee
Arizona State University · USSouthwest College of Naturopathic Medicine & Health Sciences · USWhittier College · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVitamin/mineral supplements are among the most commonly used treatments for autism, but the research on their use for treating autism has been limited.

methodThis study is a randomized, double-blind, placebo-controlled three month vitamin/mineral treatment study. The study involved 141 children and adults with autism, and pre and post symptoms of autism were assessed. None of the participants had taken a vitamin/mineral supplement in the two months prior to the start of the study. For a subset of the participants (53 children ages 5-16) pre and post measurements of nutritional and metabolic status were also conducted.

resultsThe vitamin/mineral supplement was generally well-tolerated, and individually titrated to optimum benefit. Levels of many vitamins, minerals, and biomarkers improved/increased showing good compliance and absorption. Statistically significant improvements in metabolic status were many including: total sulfate (+17%, p = 0.001), S-adenosylmethionine (SAM; +6%, p = 0.003), reduced glutathione (+17%, p = 0.0008), ratio of oxidized glutathione to reduced glutathione (GSSG:GSH; -27%, p = 0.002), nitrotyrosine (-29%, p = 0.004), ATP (+25%, p = 0.000001), NADH (+28%, p = 0.0002), and NADPH (+30%, p = 0.001). Most of these metabolic biomarkers improved to normal or near-normal levels.The supplement group had significantly greater improvements than the placebo group on the Parental Global Impressions-Revised (PGI-R, Average Change, p = 0.008), and on the subscores for Hyperactivity (p = 0.003), Tantrumming (p = 0.009), Overall (p = 0.02), and Receptive Language (p = 0.03). For the other three assessment tools the difference between treatment group and placebo group was not statistically significant.Regression analysis revealed that the degree of improvement on the Average Change of the PGI-R was strongly associated with several biomarkers (adj. R2 = 0.61, p < 0.0005) with the initial levels of biotin and vitamin K being the most significant (p < 0.05); both biotin and vitamin K are made by beneficial intestinal flora.

conclusionsOral vitamin/mineral supplementation is beneficial in improving the nutritional and metabolic status of children with autism, including improvements in methylation, glutathione, oxidative stress, sulfation, ATP, NADH, and NADPH. The supplement group had significantly greater improvements than did the placebo group on the PGI-R Average Change. This suggests that a vitamin/mineral supplement is a reasonable adjunct therapy to consider for most children and adults with autism.

trial registrationCLINICAL TRIAL REGISTRATION NUMBER: NCT01225198.

Indexed as

Dietary SupplementsAdolescentAdultAutistic DisorderChildChild BehaviorChild, PreschoolDose-Response Relationship, DrugDouble-Blind MethodFemaleFollow-Up StudiesHumansMaleMiddle AgedNutritional SupportProspective StudiesTrace ElementsVitamins

Identifiers

PMID22151477
PMCPMC3266205
OpenAlexW2104193444

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.