Evidence map›Paper›PMID 19823814›Full record

ReviewEuropean journal of clinical pharmacology2010

Dosage and formulation issues: oral vitamin E therapy in children.

Tone Westergren, Betty Kalikstad

Registry-linked trialOpen access · hybridAbstract readReview
In one paragraph

Review in European journal of clinical pharmacology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03582384 (Use of Tocofersolan), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.3field-weighted citation impact, top 16% 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.

NCT03582384 phase2withdrawnnot on this mapstarted 2020, after this paper: background citation

Use of Tocofersolan (Vedrop®) to Prevent or Treat Refractive Vitamin E Deficiency in Infants and Children

TypeinterventionalSponsorBoston Children's HospitalRan2020 to 2023Enrolled0ConditionsShort Bowel Syndrome, Vitamin E DeficiencyArmsTocofersolan
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 37 citations in OpenAlex.

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  4. Review
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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

2 authors at 2 institutions in 1 country.

Tone WestergrenRELIS, Regional Medicines Information Center, Oslo University Hospital, Rikshospitalet, Oslo, Norway. tone.westergren@rikshospitalet.no
Betty Kalikstad
Med-Storm Innovation (Norway) · NOOslo University Hospital · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeOral vitamin E is used in several childhood diseases, but dosage recommendations differ. Few oral products have a marketing authorization for therapeutic use in children. Preliminary data indicate differences in bioavailability among the various vitamin E compounds. Our objective was to review published data on oral vitamin E therapy in neonates and children in order to establish dosage recommendations at a local level.

methodsA literature search was conducted, including Medline Ovid, EMBASE (1980-Feb 2008), Cochrane databases, product monographs, handbooks, and textbooks.

resultsThe main vitamin E compounds being used in children are alpha-tocopherol, alpha-tocopheryl acetate, and tocofersolan. The most data are available on tocopheryl acetate, both in neonates and older children. In children with malabsorption disorders, tocofersolan appears to have an increased bioavailability compared to tocopherol or tocopheryl acetate. Published data on pharmacokinetics and dosages for clinical use are few and heterogeneous. No pharmacokinetic studies were found for tocofersolan in neonates and infants. There are few comparative studies on pharmacokinetics, therapeutic use, and adverse drug reactions (ADRs) in children. Dosages used in clinical studies and dosage recommendations in handbooks differ considerably.

conclusionsThe differences in dosing recommendations in children may be due to lack of systematic studies. Existing published data on oral vitamin E do not provide a basis for evaluation of dosage recommendations in children. Comparative clinical studies are required for scientific evaluation of pharmacokinetics, dosage regimens, and efficacy/ADR assessments in children.

Indexed as

Administration, OralAdolescentChemistry, PharmaceuticalChildChild, PreschoolClinical Trials as TopicDose-Response Relationship, DrugHumansInfantInfant, NewbornPractice Guidelines as TopicVitamin EVitamin E

Identifiers

PMID19823814
PMCPMC2805799
OpenAlexW1970914350

What OpenQuestion holds

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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.