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

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 registration ISRCTN13916953 Registered: 14 January 2013.

A reduced-carbohydrate and lactose-free formulation for stabilization among hospitalized children with severe acute malnutrition: A double-blind, randomized controlled trial

“…This study also directly informs this debate and suggests that reducing the carbohydrate content during transition or rehabilitation might not impact clinical outcome. There is one recent trial from our group that supports this, although more and larger trials are needed for generalizability [39]. The main limitation of the study is that the main outcome, stabilization with transition to the next phase of therapy, was based on WHO guidelines, comprising clinical evidence of recovery from acute illness as well as metabolic stabilization evidenced by recovery of appetite.…”

Design and application of a novel two-amplicon approach for defining eukaryotic microbiota

“…We applied a two-amplicon approach to investigate the eukaryotic microbiota in stool from Malawian children hospitalized with complicated SAM [26, 27]. Due to limited DNA, we amplified sufficient 18S rRNA gene V4 V5 and transITS amplicons from 44 and 46 samples, respectively.…”

“…We design and validate universal DNA amplicon primers for these two regions using a diverse panel of eukaryotes. We subsequently demonstrate the effectiveness of our approach to survey eukaryotic microbiota in a study of stool samples from 46 Malawian children hospitalized for Severe Acute Malnutrition (SAM) [26, 27], a cohort with a high expected prevalence of intestinal parasites. We show that in addition to fungi, protozoa and helminths are prevalent in this cohort.…”

Effectiveness of Interventions for Managing Acute Malnutrition in Children under Five Years of Age in Low-Income and Middle-Income Countries: A Systematic Review and Meta-Analysis

“…Two studies [44,63] assessed community-based strategies: one study compared an integrated communitybased protocol to manage MAM and SAM with no community-based strategies, while the other one compared the cost-effectiveness of existing health services with CMAM to the existing health services without CMAM. Seven studies [24,30,35,50,57,59,62] assessed facility-based strategies compared to other standards of care. Three studies [24,30,50] assessed cost-effectiveness of inpatient rehabilitation compared to outpatient or community-based management.…”

“…Three studies [57,59,62] assessed inpatient management of SAM with RUTF compared to F100. Among primary outcomes, there was no evidence of difference on weight gain (MD: 2 g/kg/day; 95% CI: −0.23 to 4.23; three studies; 266 participants; I 2 : 95%; very low quality outcome) and mortality (RR: 1.20; 95% CI: 0.34 to 4.22; two studies; 168 participants; I 2 : 16%; low quality outcome) in facility-based treatment with RUTF compared to F100.…”