Evidence map›Paper›PMID 28446221›Full record

Trial reportBMC pediatrics2017

Effectiveness of three commonly used transition phase diets in the inpatient management of children with severe acute malnutrition: a pilot randomized controlled trial in Malawi.

Christian J Versloot, Wieger Voskuijl, Sara J van Vliet, Meta van den Heuvel, Jane C Carter, Ajib Phiri, Marko Kerac, Geert Tom Heikens, Patrick F van Rheenen, Robert H J Bandsma

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC pediatrics, 2017. 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
–field-weighted citation impact
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.

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

10 authors.

Christian J VerslootDepartment of Pediatric Gastroenterology, Hepatology and Nutrition, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands.
Wieger VoskuijlDepartment of Pediatrics and Child Health, College of Medicine, Blantyre, Malawi.
Sara J van VlietDepartment of Pediatric Gastroenterology, Hepatology and Nutrition, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands.
Meta van den HeuvelDepartment of Pediatric Gastroenterology, Hepatology and Nutrition, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands.
Jane C CarterDepartment of Pediatrics and Child Health, College of Medicine, Blantyre, Malawi.
Ajib PhiriDepartment of Pediatrics and Child Health, College of Medicine, Blantyre, Malawi.
Marko KeracDepartment of Population Health, London School of Hygiene and Tropical Medicine, London, UK.
Geert Tom HeikensDepartment of Pediatrics and Child Health, College of Medicine, Blantyre, Malawi.
Patrick F van RheenenDepartment of Pediatric Gastroenterology, Hepatology and Nutrition, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands.
Robert H J BandsmaDepartment of Pediatric Gastroenterology, Hepatology and Nutrition, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands. r.h.j.bandsma@umcg.nl.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe case fatality rate of severely malnourished children during inpatient treatment is high and mortality is often associated with diarrhea. As intestinal carbohydrate absorption is impaired in severe acute malnutrition (SAM), differences in dietary formulations during nutritional rehabilitation could lead to the development of osmotic diarrhea and subsequently hypovolemia and death. We compared three dietary strategies commonly used during the transition of severely malnourished children to higher caloric feeds, i.e., F100 milk (F100), Ready-to-Use Therapeutic Food (RUTF) and RUTF supplemented with F75 milk (RUTF + F75).

methodsIn this open-label pilot randomized controlled trial, 74 Malawian children with SAM aged 6-60 months, were assigned to either F100, RUTF or RUTF + F75. Our primary endpoint was the presence of low fecal pH (pH ≤ 5.5) measured in stool collected 3 days after the transition phase diets were introduced. Secondary outcomes were duration of hospital stay, diarrhea and other clinical outcomes. Chi-square test, two-way analysis of variance and logistic regression were conducted and, when appropriate, age, sex and initial weight for height Z-scores were included as covariates.

resultsThe proportion of children with acidic stool (pH ≤5.5) did not significantly differ between groups before discharge with 30, 33 and 23% for F100, RUTF and RUTF + F75, respectively. Mean duration of stay after transitioning was 7.0 days (SD 3.4) with no differences between the three feeding strategies. Diarrhea was present upon admission in 33% of patients and was significantly higher (48%) during the transition phase (p < 0.05). There was no significant difference in mortality (n = 6) between diets during the transition phase nor were there any differences in other secondary outcomes.

conclusionsThis pilot trial does not demonstrate that a particular transition phase diet is significantly better or worse since biochemical and clinical outcomes in children with SAM did not differ. However, larger and more tightly controlled efficacy studies are needed to confirm these findings.

trial registrationISRCTN13916953 Registered: 14 January 2013.

Indexed as

Food, FormulatedAnimalsChildChild, PreschoolFemaleHospitalizationHumansInfantLogistic ModelsMalawiMaleMilkPilot ProjectsSevere Acute MalnutritionTreatment OutcomeCarbohydrate malabsorptionDiarrheaF100F75Ready-to-use therapeutic foodSAM

Identifiers

PMID28446221
PMCPMC5406940

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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.