Evidence map›Paper›PMID 36880049›Full record

ArticleEClinicalMedicine2023

A novel nano-iron supplement versus standard treatment for iron deficiency anaemia in children 6-35 months (IHAT-GUT trial): a double-blind, randomised, placebo-controlled non-inferiority phase II trial in The Gambia.

Nuredin I Mohammed, James Wason, Thomas Mendy, Stefan A Nass, Ogochukwu Ofordile, Famalang Camara, Bakary Baldeh, Chilel Sanyang, Amadou T Jallow, Ilias Hossain and 4 more

Open access · goldAbstract read
In one paragraph

Article in EClinicalMedicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
4.9field-weighted citation impact, top 5% 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

14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 17 citations in OpenAlex.

  1. Pooled it
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  3. Trial
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  6. Observational
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  14. Nanomedicine Therapies for Pediatric Diseases.Wiley interdisciplinary reviews. Nanomedicine and nanobiotechnology
    Review
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

14 authors at 2 institutions in 3 countries.

Nuredin I MohammedMedical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, Gambia.
James WasonMRC Biostatistics Unit, Institute of Public Health, University of Cambridge, Cambridge, CB2 0SR, UK.
Thomas MendyMedical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, Gambia.
Stefan A NassMedical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, Gambia.
Ogochukwu OfordileMedical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, Gambia.
Famalang CamaraMedical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, Gambia.
Bakary BaldehMedical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, Gambia.
Chilel SanyangMedical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, Gambia.
Amadou T JallowMedical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, Gambia.
Ilias HossainMedical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, Gambia.
Nuno FariaDepartment of Veterinary Medicine, University of Cambridge, Madingley Road, Cambridge, CB3 0ES, UK.
Jonathan J PowellDepartment of Veterinary Medicine, University of Cambridge, Madingley Road, Cambridge, CB3 0ES, UK.
Andrew M PrenticeMedical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, Gambia.
Dora I A PereiraMedical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, Gambia.
MRC Unit the Gambia · GMUniversity of Cambridge · GB

Funding

Medical Research Council MC_U123292699Medical Research Council MC_UU_00002/6Medical Research Council MC_UU_00026/3Medical Research Council MR/R005699/1Medical Research Council MR/R010161/1
6 · The paper itself

Abstract

Background: Iron deficiency anaemia (IDA) is the leading cause of years lost to disability in most sub-Saharan African countries and is especially common in young children. The IHAT-GUT trial assessed the efficacy and safety of a novel nano iron supplement, which is a dietary ferritin analogue termed iron hydroxide adipate tartrate (IHAT), for the treatment of IDA in children under 3 years of age. Methods: In this single-country, randomised, double-blind, parallel, placebo-controlled, non-inferiority Phase II study in The Gambia, children 6-35 months with IDA (7≤Hb < 11 g/dL and ferritin<30 μg/L) were randomly assigned (1:1:1) to receive either IHAT, ferrous sulphate (FeSO Findings: Between Nov 2017 and Nov 2018, 642 children were randomised into the study (214 per group) and included in the ITT analysis, the PP population included 582 children. A total of 50/177 (28.2%) children in the IHAT group achieved the primary efficacy endpoint, as compared with 42/190 (22.1%) in the FeSO Interpretation: In this first Phase II study conducted in young children with IDA, IHAT showed sufficient non-inferiority compared to standard-of-care FeSO Funding: The Bill & Melinda Gates Foundation (OPP1140952).

Indexed as

AnaemiaChildrenClinical trialIron deficiencyIron hydroxide adipate tartrate (IHAT)Iron supplementationPhase II

Identifiers

PMID36880049
PMCPMC9985047
OpenAlexW4319750130

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.