Ready-to-use therapeutic food (RUTF)
Dietary SupplementStandard formulation meeting UNICEF specifications: https://www.unicef.org/supply/sites/unicef.org.supply/files/2023-04/U239977-RUTF-Novel-Specification.pdf
NCT Number: NCT06061484
Protocols for the community-based management of acute malnutrition (CMAM) have not changed significantly for more than 20 years, with relatively complex treatment protocols and persistent supply chain challenges that have limited overall program coverage, leaving millions of malnourished children without care annually. The overarching goal of this research project is to simultaneously test two novel simplified approaches in CMAM with potential to improve program coverage. The simplified approach includes two parallel clinical trials for SAM and MAM treatment. Two fixed-dose regimes of RUTF will be tested against the current weight-based dosing of RUTF for children with SAM.
Interested in participating?
Request Info6 month–59 month
All sexes
Interventional
Not applicable
Sekota, Amhara, Ethiopia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Standard formulation meeting UNICEF specifications: https://www.unicef.org/supply/sites/unicef.org.supply/files/2023-04/U239977-RUTF-Novel-Specification.pdf
Standard weight-based dosing per Ehtiopian national guidelines
Time frame: up to 16 weeks
two consecutive weeks with MUAC > 12.4 cm and/or WHZ >= -2 and/or resolution of edema, depending on enrollment criteria
Time frame: weekly for up to 16 weeks
Time frame: weekly for up to 16 weeks
Time frame: weekly for up to 16 weeks
Time frame: up to weekly for up to 16 weeks
Time frame: up to weekly for up to 16 weeks
Time frame: up to weekly for up to 16 weeks
Time frame: up to weekly for up to 16 weeks
Time frame: up to weekly for up to 16 weeks
Time frame: weekly for up to 16 weeks
Time frame: up to 16 weeks
Time frame: up to 16 weeks
Time frame: up to 16 weeks
Time frame: up to 6 months post-recovery
calculated as number of children who die divided by total number of children initially enrolled
Time frame: up to 6 months post-recovery
calculated as number of children who develop acute malnutrition by the total number of children initially enrolled
Time frame: up to 6 months post-recovery
Time frame: up to 6 months post-recovery
Time frame: up to 6 months post-recovery
Time frame: up to 6 months post-recovery
Time frame: up to 6 months post-recovery
Time frame: 6 months post-recovery
Time frame: 6 months post-recovery
Time frame: 6 months post-recovery
Time frame: 6 months post-recovery
Time frame: 6 months post-recovery
Time frame: 6 months post-recovery
Time frame: up to 16 weeks
calculated as the total costs of the treatment for all children divided by the number of children who achieve nutritional recovery
Time frame: 6 months post-recovery
calculated as the total costs of the treatment for all children divided by the number of children who sustain nutritional recovery
Contact information is provided by the study sponsor or research team.
Action Against Hunger USA
Other
Safety Efficacy, and Cost-effectiveness of Modified Doses of Ready-to-use Therapeutic Food for the Treatment of Severe Acute Malnutrition Among Children 6-59 Months of Age in Ethiopia
Acronym: MODAM-SAM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06593080
Actinomycetales Infections, Bacterial Infections
Chingola, Copperbelt, Zambia
View Trial DetailsNCT06154174
Body Weight, Body Weight Changes
Makhwira, Chikwawa, Malawi
View Trial DetailsNCT06869850
Body Weight, Body Weight Changes
Bandajuma, Pujehun, Sierra Leone
View Trial DetailsNCT06010719
Child Nutrition Disorders, Malnutrition
Nouna, Kossi, Burkina Faso
View Trial Details