TY - JOUR
T1 - A protocol for a proof-of-concept randomized control trial testing increased protein quantity and quality in ready-to-use therapeutic food in improving linear growth among 6-23-month-old children with severe wasting in Malawi
AU - Potani, Isabel
AU - Daniel, Allison I.
AU - Briend, André
AU - Courtney-Martin, Glenda
AU - Berkley, James A.
AU - Voskuijl, Wieger
AU - Vresk, Laura
AU - Bourdon, Celine
AU - Kathumba, Sylvester
AU - Mbale, Emmie
AU - Bandsma, Robert H. J.
N1 - Funding Information: IP received funding from the Schlumberger Faculty for the future Foundation (USD40,000), https://www.slb.com/about/who-weare/schlumberger-foundation and the SickKids Centre for Global Child Health (USD18,000), https://www.sickkids.ca/siteassets/care–services/ centres/global-child-health/catalyst-grant-documents/catalystgrant-guidelines-2023.pdf. Both grants are for early career researchers, e.g., PhD students and did not have grant numbers. The funders did not and will not have a role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. We would like to thank Agnes Malamula, Chisomo Eneya, Chikondi Masamba-Makanani, Chikondi Makwinja, Linda Alinane Nyondo-Mipando, Kim Michaelsen, Hannah Pesu, Ann-Sophie Iuel-Brockdorf, Takondwa Mbulaje, Faith Kalyolyo, Abel Tembo, Dennis Chasweka, Frank Ziwoya, and Stanley Khoswe for their contributions in developing the data collection tools and implementing the study. We would also like to thank Drs Kenneth Maleta, Felix Namboya and Noel Patson for their role in the DSMB. We are also thankful to Nutriset, Malaunay, France for providing the investigational products at no cost. Publisher Copyright: © 2023 Potani et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
PY - 2023/8/24
Y1 - 2023/8/24
N2 - Introduction Ready-to-use therapeutic foods (RUTFs) have successfully promoted recovery from severe wasting and increased treatment coverage. However, RUTFs do not sufficiently improve linear growth, leaving many survivors of severe wasting at risk of persistent stunting, which is associated with high mortality risk, poor child development and non-communicable diseases in adulthood. High protein quantity and quality can stimulate linear growth. Aim The trial aims to assess whether higher-protein-RUTF leads to higher concentrations of markers of linear growth compared to standard RUTF among 6–23 months old children with severe wasting. Methods We designed a higher protein quantity and quality RUTF for a proof-of-concept (PoC) double-blind randomized controlled trial. Outcomes The primary outcome is a change in insulin-like growth factor-1 (IGF-1), a hormone positively associated with linear growth after four weeks of treatment. Secondary outcomes include changes in ponderal and linear growth and in body composition from baseline to eight weeks later; plasma amino acid profile at four weeks; acceptability and safety. Implications These findings will help in informing the potential impact of increased protein in RUTF on linear growth when treating severe wasting towards conducting a larger clinical trial.
AB - Introduction Ready-to-use therapeutic foods (RUTFs) have successfully promoted recovery from severe wasting and increased treatment coverage. However, RUTFs do not sufficiently improve linear growth, leaving many survivors of severe wasting at risk of persistent stunting, which is associated with high mortality risk, poor child development and non-communicable diseases in adulthood. High protein quantity and quality can stimulate linear growth. Aim The trial aims to assess whether higher-protein-RUTF leads to higher concentrations of markers of linear growth compared to standard RUTF among 6–23 months old children with severe wasting. Methods We designed a higher protein quantity and quality RUTF for a proof-of-concept (PoC) double-blind randomized controlled trial. Outcomes The primary outcome is a change in insulin-like growth factor-1 (IGF-1), a hormone positively associated with linear growth after four weeks of treatment. Secondary outcomes include changes in ponderal and linear growth and in body composition from baseline to eight weeks later; plasma amino acid profile at four weeks; acceptability and safety. Implications These findings will help in informing the potential impact of increased protein in RUTF on linear growth when treating severe wasting towards conducting a larger clinical trial.
UR - http://www.scopus.com/inward/record.url?scp=85168750023&partnerID=8YFLogxK
U2 - https://doi.org/10.1371/journal.pone.0287680
DO - https://doi.org/10.1371/journal.pone.0287680
M3 - Article
C2 - 37619218
SN - 1932-6203
VL - 18
SP - e0287680
JO - PLOS ONE
JF - PLOS ONE
IS - 8 August
M1 - e0287680
ER -