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

Robert H. J. Bandsma, Wieger Voskuijl, Emmanuel Chimwezi, Greg Fegan, André Briend, Johnstone Thitiri, Moses Ngari, Laura Mwalekwa, Victor Bandika, Rehema Ali, Fauzat Hamid, Betty Owor, Neema Mturi, Isabel Potani, Benjamin Allubha, Anneke C. Muller Kobold, Rosalie H. Bartels, Christian J. Versloot, Marjon Feenstra, Deborah A. van den Brink, Patrick F. van Rheenen, Marko Kerac, Celine Bourdon, James A. Berkley

PLOS Medicine, Volume: 16, Issue: 2, Start page: e1002747

Swansea University Author: Greg Fegan

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DOI (Published version): 10.1371/journal.pmed.1002747

Abstract

BackgroundChildren 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...

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ISSN: 1549-1676
Published: 2019
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fullrecord <?xml version="1.0"?><rfc1807><datestamp>2020-06-24T18:52:56.6950136</datestamp><bib-version>v2</bib-version><id>49104</id><entry>2019-03-04</entry><title>A reduced-carbohydrate and lactose-free formulation for stabilization among hospitalized children with severe acute malnutrition: A double-blind, randomized controlled trial</title><swanseaauthors><author><sid>a9005418b89918776f3d8895ba42e850</sid><firstname>Greg</firstname><surname>Fegan</surname><name>Greg Fegan</name><active>true</active><ethesisStudent>false</ethesisStudent></author></swanseaauthors><date>2019-03-04</date><deptcode>FGMHL</deptcode><abstract>BackgroundChildren 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.Methods and findingsIn 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 F75 and 188 (44%) to mF75 had diarrhea at admission. Median time to stabilization was 3 days (IQR 2&#x2013;5 days), which was similar between randomized groups (0.23 [95% CI &#x2212;0.13 to 0.60], P = 0.59). There was no evidence of effect modification by diarrhea at admission,age, edema, or HIV status. Thirty-six and 39 children died before stabilization in the F75 and in mF75 arm, respectively (P = 0.84). Cumulative days with diarrhea (P = 0.27), enteral (P = 0.42) or intravenous fluids (P = 0.19), other serious adverse events before stabilization, and serum and stool biochemistry at day 3 did not differ between groups. The main limitation was that the primary outcome of clinical stabilization was based on WHO guidelines, comprising clinical evidence of recovery from acute illness as well as metabolic stabilization evidenced by recovery of appetite. ConclusionsEmpirically treating hospitalized severely malnourished children during the stabilization phase with lactose-free, reduced-carbohydrate milk formula did not improve clinical outcomes. The biochemical analyses suggest that the lactose-free formulae may still exceed a carbohydrate load threshold for intestinal absorption, which may limit their usefulness in the context of complicated SAM.</abstract><type>Journal Article</type><journal>PLOS Medicine</journal><volume>16</volume><journalNumber>2</journalNumber><paginationStart>e1002747</paginationStart><publisher/><issnElectronic>1549-1676</issnElectronic><keywords/><publishedDay>26</publishedDay><publishedMonth>2</publishedMonth><publishedYear>2019</publishedYear><publishedDate>2019-02-26</publishedDate><doi>10.1371/journal.pmed.1002747</doi><url>https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002747</url><notes/><college>COLLEGE NANME</college><department>Medicine, Health and Life Science - Faculty</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>FGMHL</DepartmentCode><institution>Swansea University</institution><apcterm/><lastEdited>2020-06-24T18:52:56.6950136</lastEdited><Created>2019-03-04T10:06:31.1808958</Created><path><level id="1">Faculty of Medicine, Health and Life Sciences</level><level id="2">Swansea University Medical School - Medicine</level></path><authors><author><firstname>Robert H. J.</firstname><surname>Bandsma</surname><order>1</order></author><author><firstname>Wieger</firstname><surname>Voskuijl</surname><order>2</order></author><author><firstname>Emmanuel</firstname><surname>Chimwezi</surname><order>3</order></author><author><firstname>Greg</firstname><surname>Fegan</surname><order>4</order></author><author><firstname>Andr&#xE9;</firstname><surname>Briend</surname><order>5</order></author><author><firstname>Johnstone</firstname><surname>Thitiri</surname><order>6</order></author><author><firstname>Moses</firstname><surname>Ngari</surname><order>7</order></author><author><firstname>Laura</firstname><surname>Mwalekwa</surname><order>8</order></author><author><firstname>Victor</firstname><surname>Bandika</surname><order>9</order></author><author><firstname>Rehema</firstname><surname>Ali</surname><order>10</order></author><author><firstname>Fauzat</firstname><surname>Hamid</surname><order>11</order></author><author><firstname>Betty</firstname><surname>Owor</surname><order>12</order></author><author><firstname>Neema</firstname><surname>Mturi</surname><order>13</order></author><author><firstname>Isabel</firstname><surname>Potani</surname><order>14</order></author><author><firstname>Benjamin</firstname><surname>Allubha</surname><order>15</order></author><author><firstname>Anneke C. Muller</firstname><surname>Kobold</surname><order>16</order></author><author><firstname>Rosalie H.</firstname><surname>Bartels</surname><order>17</order></author><author><firstname>Christian J.</firstname><surname>Versloot</surname><order>18</order></author><author><firstname>Marjon</firstname><surname>Feenstra</surname><order>19</order></author><author><firstname>Deborah A. van den</firstname><surname>Brink</surname><order>20</order></author><author><firstname>Patrick F. van</firstname><surname>Rheenen</surname><order>21</order></author><author><firstname>Marko</firstname><surname>Kerac</surname><order>22</order></author><author><firstname>Celine</firstname><surname>Bourdon</surname><order>23</order></author><author><firstname>James A.</firstname><surname>Berkley</surname><order>24</order></author></authors><documents><document><filename>0049104-04032019104030.pdf</filename><originalFilename>BandsmaR_PLoSMed_2019.pdf</originalFilename><uploaded>2019-03-04T10:40:30.3030000</uploaded><type>Output</type><contentLength>1171909</contentLength><contentType>application/pdf</contentType><version>Version of Record</version><cronfaStatus>true</cronfaStatus><embargoDate>2019-02-26T00:00:00.0000000</embargoDate><documentNotes>This is an open access article distributed under the terms of the Creative Commons Attribution License.</documentNotes><copyrightCorrect>true</copyrightCorrect><language>eng</language></document></documents><OutputDurs/></rfc1807>
spelling 2020-06-24T18:52:56.6950136 v2 49104 2019-03-04 A reduced-carbohydrate and lactose-free formulation for stabilization among hospitalized children with severe acute malnutrition: A double-blind, randomized controlled trial a9005418b89918776f3d8895ba42e850 Greg Fegan Greg Fegan true false 2019-03-04 FGMHL BackgroundChildren 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.Methods and findingsIn 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 F75 and 188 (44%) to mF75 had diarrhea at admission. Median time to stabilization was 3 days (IQR 2–5 days), which was similar between randomized groups (0.23 [95% CI −0.13 to 0.60], P = 0.59). There was no evidence of effect modification by diarrhea at admission,age, edema, or HIV status. Thirty-six and 39 children died before stabilization in the F75 and in mF75 arm, respectively (P = 0.84). Cumulative days with diarrhea (P = 0.27), enteral (P = 0.42) or intravenous fluids (P = 0.19), other serious adverse events before stabilization, and serum and stool biochemistry at day 3 did not differ between groups. The main limitation was that the primary outcome of clinical stabilization was based on WHO guidelines, comprising clinical evidence of recovery from acute illness as well as metabolic stabilization evidenced by recovery of appetite. ConclusionsEmpirically treating hospitalized severely malnourished children during the stabilization phase with lactose-free, reduced-carbohydrate milk formula did not improve clinical outcomes. The biochemical analyses suggest that the lactose-free formulae may still exceed a carbohydrate load threshold for intestinal absorption, which may limit their usefulness in the context of complicated SAM. Journal Article PLOS Medicine 16 2 e1002747 1549-1676 26 2 2019 2019-02-26 10.1371/journal.pmed.1002747 https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002747 COLLEGE NANME Medicine, Health and Life Science - Faculty COLLEGE CODE FGMHL Swansea University 2020-06-24T18:52:56.6950136 2019-03-04T10:06:31.1808958 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine Robert H. J. Bandsma 1 Wieger Voskuijl 2 Emmanuel Chimwezi 3 Greg Fegan 4 André Briend 5 Johnstone Thitiri 6 Moses Ngari 7 Laura Mwalekwa 8 Victor Bandika 9 Rehema Ali 10 Fauzat Hamid 11 Betty Owor 12 Neema Mturi 13 Isabel Potani 14 Benjamin Allubha 15 Anneke C. Muller Kobold 16 Rosalie H. Bartels 17 Christian J. Versloot 18 Marjon Feenstra 19 Deborah A. van den Brink 20 Patrick F. van Rheenen 21 Marko Kerac 22 Celine Bourdon 23 James A. Berkley 24 0049104-04032019104030.pdf BandsmaR_PLoSMed_2019.pdf 2019-03-04T10:40:30.3030000 Output 1171909 application/pdf Version of Record true 2019-02-26T00:00:00.0000000 This is an open access article distributed under the terms of the Creative Commons Attribution License. true eng
title A reduced-carbohydrate and lactose-free formulation for stabilization among hospitalized children with severe acute malnutrition: A double-blind, randomized controlled trial
spellingShingle A reduced-carbohydrate and lactose-free formulation for stabilization among hospitalized children with severe acute malnutrition: A double-blind, randomized controlled trial
Greg Fegan
title_short A reduced-carbohydrate and lactose-free formulation for stabilization among hospitalized children with severe acute malnutrition: A double-blind, randomized controlled trial
title_full A reduced-carbohydrate and lactose-free formulation for stabilization among hospitalized children with severe acute malnutrition: A double-blind, randomized controlled trial
title_fullStr A reduced-carbohydrate and lactose-free formulation for stabilization among hospitalized children with severe acute malnutrition: A double-blind, randomized controlled trial
title_full_unstemmed A reduced-carbohydrate and lactose-free formulation for stabilization among hospitalized children with severe acute malnutrition: A double-blind, randomized controlled trial
title_sort A reduced-carbohydrate and lactose-free formulation for stabilization among hospitalized children with severe acute malnutrition: A double-blind, randomized controlled trial
author_id_str_mv a9005418b89918776f3d8895ba42e850
author_id_fullname_str_mv a9005418b89918776f3d8895ba42e850_***_Greg Fegan
author Greg Fegan
author2 Robert H. J. Bandsma
Wieger Voskuijl
Emmanuel Chimwezi
Greg Fegan
André Briend
Johnstone Thitiri
Moses Ngari
Laura Mwalekwa
Victor Bandika
Rehema Ali
Fauzat Hamid
Betty Owor
Neema Mturi
Isabel Potani
Benjamin Allubha
Anneke C. Muller Kobold
Rosalie H. Bartels
Christian J. Versloot
Marjon Feenstra
Deborah A. van den Brink
Patrick F. van Rheenen
Marko Kerac
Celine Bourdon
James A. Berkley
format Journal article
container_title PLOS Medicine
container_volume 16
container_issue 2
container_start_page e1002747
publishDate 2019
institution Swansea University
issn 1549-1676
doi_str_mv 10.1371/journal.pmed.1002747
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Medicine{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Medicine
url https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002747
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active_str 0
description BackgroundChildren 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.Methods and findingsIn 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 F75 and 188 (44%) to mF75 had diarrhea at admission. Median time to stabilization was 3 days (IQR 2–5 days), which was similar between randomized groups (0.23 [95% CI −0.13 to 0.60], P = 0.59). There was no evidence of effect modification by diarrhea at admission,age, edema, or HIV status. Thirty-six and 39 children died before stabilization in the F75 and in mF75 arm, respectively (P = 0.84). Cumulative days with diarrhea (P = 0.27), enteral (P = 0.42) or intravenous fluids (P = 0.19), other serious adverse events before stabilization, and serum and stool biochemistry at day 3 did not differ between groups. The main limitation was that the primary outcome of clinical stabilization was based on WHO guidelines, comprising clinical evidence of recovery from acute illness as well as metabolic stabilization evidenced by recovery of appetite. ConclusionsEmpirically treating hospitalized severely malnourished children during the stabilization phase with lactose-free, reduced-carbohydrate milk formula did not improve clinical outcomes. The biochemical analyses suggest that the lactose-free formulae may still exceed a carbohydrate load threshold for intestinal absorption, which may limit their usefulness in the context of complicated SAM.
published_date 2019-02-26T03:59:53Z
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