Evidence map›Paper›PMID 32191814›Full record

Trial reportPediatrics international : official journal of the Japan Pediatric Society2020

Ferrous sulfate oral solution in young children with iron deficiency anemia: An open-label trial of efficacy, safety, and acceptability.

Lidia Pachuta Węgier, Maciej Kubiak, Agata Liebert, Thierry Clavel, Agnès Montagne, Aline Stennevin, Sandrine Roye, Asmaa Boudribila

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Pediatrics international : official journal of the Japan Pediatric Society, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.5field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  5. Review
  6. Article
  7. 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

8 authors at 3 institutions in 2 countries.

Lidia Pachuta WęgierLidia Pachuta Węgier Medical Services, Lublin, Poland.
Maciej KubiakTolek Clinic for Children, Lesznowola, Poland.
Agata LiebertTolek Clinic for Children, Lesznowola, Poland.
Thierry ClavelTCC Consulting, Revel, France.
Agnès MontagneClinical Development Department, Institut de Recherche Pierre Fabre, CRDPF, Toulouse, France.
Aline StennevinClinical Development Department, Institut de Recherche Pierre Fabre, CRDPF, Toulouse, France.
Sandrine RoyeClinical Development Department, Institut de Recherche Pierre Fabre, CRDPF, Toulouse, France.
Asmaa BoudribilaClinical Development Department, Institut de Recherche Pierre Fabre, CRDPF, Toulouse, France.ORCID https://orcid.org/0000-0003-0527-9816
Pierre Fabre (France) · FRUniwersytecki Szpital Dziecięcy · PLMNM Consulting (France) · FR

Funding

Pierre Fabre Médicament
6 · The paper itself

Abstract

backgroundThis study evaluated the efficacy, safety, and acceptability of a new ferrous sulfate oral solution (Tardyferon® 20 mg/mL) in young children with mild or moderate iron deficiency anemia (IDA).

methodsThis was a multicenter, national, single-arm, open-label study. Children aged 6-53 months presenting with mild or moderate IDA (i.e., blood hemoglobin (Hb) ranging from 7.0 to 10.9 g/dL and serum ferritin <12 ng/mL) were eligible for inclusion. The ferrous sulfate heptahydrate solution (2 mg/kg/day) was administered orally for 3 months. If normalization of either Hb or ferritin was not achieved at month 3 the treatment was continued for another 3 months.

resultsOf the 100 children screened, 21 aged 6-17 months were included and received the study treatment, and 19 were analyzed for hematologic outcomes at month 3. Only one patient continued treatment for the additional 3 months. At month 3, mean ± SD Hb and ferritin levels were 12.0 ± 0.7 g/dL and 31.5 ± 19.4 ng/mL, respectively. Hemoglobin and ferritin levels were normalized in 95% (18/19) and 84% (16/19) of the patients, respectively. Treatment compliance and levels of satisfaction of both the parents and the investigators were high. Overall, 33.3% of patients (7/21) experienced at least one adverse event. Only one patient (4.8%) experienced a drug-related adverse event (upper abdominal pain).

conclusionsA 2 mg/kg daily dose of the new oral ferrous sulfate heptahydrate solution provides substantial therapeutic benefit with high levels of tolerability in young children who have mild or moderate IDA.

Indexed as

Administration, OralAnemia, Iron-DeficiencyChild, PreschoolDrug CombinationsFemaleFerritinsFerrous CompoundsHemoglobinsHumansInfantMaleMucinsTreatment OutcomeDrug CombinationsFerritinsFerrous Compoundsferrous sulfate, mucin drug combinationHemoglobinsMucinsferrous sulfateinfantiron deficiency anemiapreschool child

Identifiers

PMID32191814
PMCPMC7496601
OpenAlexW3012451213

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.