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

PLoS Medicine
Robert H J BandsmaJames A Berkley

Abstract

Children with medically complicated severe acute malnutrition (SAM) have high risk of inpatient mortality. Diarrhea, carbohydrate malabsorption, and refeeding syndrome may contribute to early mortality and delayed recovery. We tested the hypothesis that a lactose-free, low-carbohydrate F75 milk would serve to limit these risks, thereby reducing the number of days in the stabilization phase. In a multicenter double-blind trial, hospitalized severely malnourished children were randomized to receive standard formula (F75) or isocaloric modified F75 (mF75) without lactose and with reduced carbohydrate. The primary endpoint was time to stabilization, as defined by the World Health Organization (WHO), with intention-to-treat analysis. Secondary outcomes included in-hospital mortality, diarrhea, and biochemical features of malabsorption and refeeding syndrome. The trial was registered at clinicaltrials.gov (NCT02246296). Four hundred eighteen and 425 severely malnourished children were randomized to F75 and mF75, respectively, with 516 (61%) enrolled in Kenya and 327 (39%) in Malawi. Children with a median age of 16 months were enrolled between 4 December 2014 and 24 December 2015. One hundred ninety-four (46%) children assigned to F7...Continue Reading

Associated Clinical Trials

References

Oct 1, 1969·Archives of Disease in Childhood·J G PrinslooS A Fellingham
Nov 2, 2002·Journal of Paediatrics and Child Health·R H Kukuruzovic, D R Brewster
Dec 3, 2003·Best Practice & Research. Clinical Gastroenterology·Ernest M WrightEric Turk
Dec 5, 2006·Lancet·Steve CollinsAlistair Hallam
Sep 17, 2010·The Journal of Pediatrics·Robert H J BandsmaGeert Tom Heikens
Dec 8, 2010·British Journal of Hospital Medicine·Clare OrmerodSimon Lal
Mar 6, 2012·Metabolism: Clinical and Experimental·Martijn N SpoelstraRobert H J Bandsma
Sep 18, 2012·Pediatrics International : Official Journal of the Japan Pediatric Society·Shoji YoshimatsuTahmeed Ahmed
Dec 25, 2012·JPEN. Journal of Parenteral and Enteral Nutrition·Laura E Matarese
Feb 1, 2013·The New England Journal of Medicine·Indi TrehanMark J Manary
Jun 12, 2013·Lancet·Zulfiqar A BhuttaUNKNOWN Lancet Nutrition Interventions Review Group, the Maternal and Child Nutrition Study Group
Nov 26, 2014·Archives of Disease in Childhood·Indi Trehan, Mark J Manary
Apr 4, 2015·The American Journal of Clinical Nutrition·Sakib BurzaKripa Nath Mishra
Nov 19, 2015·Nutrition Reviews·Matilda A KvissbergRobert H J Bandsma
Dec 30, 2016·The American Journal of Clinical Nutrition·Maren Jh RytterHenrik Friis
May 16, 2018·Journal of Pediatric Gastroenterology and Nutrition·Jan de LaffolieKlaus-Peter Zimmer

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Citations

Feb 23, 2020·Journal of Pediatric Gastroenterology and Nutrition·Alfredo GuarinoSuporn Treepongkaruna
Nov 11, 2020·Hospital Pediatrics·Megan E CoeClifton C Lee
Oct 25, 2020·Clinical Nutrition : Official Journal of the European Society of Parenteral and Enteral Nutrition·Céline BourdonWieger P Voskuijl

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Clinical Trials Mentioned

ISRCTN98124592
NCT02246296

Software Mentioned

Stata
cmprsk R - package
R

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