Evidence map›Paper›PMID 20868469›Full record

Trial reportLipids in health and disease2010

Supplementation of polyunsaturated fatty acids, magnesium and zinc in children seeking medical advice for attention-deficit/hyperactivity problems - an observational cohort study.

Michael Huss, Andreas Völp, Manuela Stauss-Grabo

Registry-linked trialOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in Lipids in health and disease, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01340690 (PAD-study), which is not on this map. Cited by 31 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 2 pooled it
2.1field-weighted citation impact, top 14% 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.

NCT01340690 phase3terminatednot on this mapstarted 2011, after this paper: background citation

PAD-study: Nutritional Efficacy of Polyunsaturated Fatty Acids (Omega-3 and Omega-6) in Combination With Zinc and Magnesium Versus Placebo in Children and Adolescents With Attention Deficit/ Hyperactivity Disorder (ADHD)

TypeinterventionalSponsorJohannes Gutenberg University MainzRan2011 to 2017Enrolled284ConditionsADHDArmsω-3 fatty acids suspension, placebo suspension
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 2 syntheses or guidelines pooled it, 76 citations in OpenAlex.

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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

3 authors at 3 institutions in 1 country.

Michael HussDepartment for Child and Adolescent Psychiatry, Johannes Gutenberg-University, Mainz, Langenbeckstr. 1; 55131 Mainz, Germany. michael.huss@ukmainz.de
Andreas Völp
Manuela Stauss-Grabo
Engelhard Arzneimittel (Germany) · DEFuchs (Germany) · DEJohannes Gutenberg University Mainz · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPolyunsaturated fatty acids are essential nutrients for humans. They are structural and functional components of cell membranes and pre-stages of the hormonally and immunologically active eicosanoids. Recent discoveries have shown that the long-chained omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) also play an important role in the central nervous system. They are essential for normal brain functioning including attention and other neuropsychological skills. MATERIALS AND

methodsIn our large observational study we monitored 810 children from 5 to 12 years of age referred for medical help and recommended for consuming polyunsaturated fatty acids (PUFA) in combination with zinc and magnesium by a physician over a period of at least 3 months. The food supplement ESPRICO® (further on referred to as the food supplement) is developed on the basis of current nutritional science and containing a combination of omega-3 and omega-6 fatty acids as well as magnesium and zinc. Study objective was to evaluate the nutritional effects of the PUFA-zinc-magnesium combination on symptoms of attention deficit, impulsivity, and hyperactivity as well as on emotional problems and sleep related parameters. Assessment was performed by internationally standardised evaluation scales, i.e. SNAP-IV and SDQ. Tolerance (adverse events) and acceptance (compliance) of the dietary therapy were documented.

resultsAfter 12 weeks of consumption of a combination of omega-3 and omega-6 fatty acids as well as magnesium and zinc most subjects showed a considerable reduction in symptoms of attention deficit and hyperactivity/impulsivity assessed by SNAP-IV. Further, the assessment by SDQ revealed fewer emotional problems at the end of the study period compared to baseline and also sleeping disorders. Mainly problems to fall asleep, decreased during the 12 week nutritional therapy. Regarding safety, no serious adverse events occurred. A total of 16 adverse events with a possible causal relationship to the study medication were reported by 14 children (1.7%) and only 5.2% of the children discontinued the study due to acceptance problems. Continuation of consumption of the food supplement was recommended by the paediatricians for 61.1% of the children.

conclusionOur results suggest a beneficial effect of a combination of omega-3 and omega-6 fatty acids as well as magnesium and zinc consumption on attentional, behavioural, and emotional problems of children and adolescents. Thus, considering the behavioural benefit in combination with the low risk due to a good safety profile, the dietary supplementation with PUFA in combination with zinc and magnesium can be recommended.

Indexed as

Dietary SupplementsAdolescentAffective SymptomsAttentionAttention Deficit Disorder with HyperactivityChildChild, PreschoolCohort StudiesFatty Acids, Omega-3Fatty Acids, Omega-6FemaleHumansHyperkinesisImpulsive BehaviorMagnesiumMaleFatty Acids, Omega-3Fatty Acids, Omega-6MagnesiumZinc

Identifiers

PMID20868469
PMCPMC2955638
OpenAlexW2171114624

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.