Clinical Trials Logo

Clinical Trial Summary

This is a proof-of-concept trial that aims to compare the efficacy of an 8-week treatment with higher-protein-Ready-to-Use Therapeutic Foods (RUTF) with standard RUTF in improving levels of markers of growths, height, nutritional recovery, and lean mass deposition among children with severe wasting. The study will also assess the safety and acceptability of the high-protein RUTF in comparison to the standard RUTF. The study will be conducted at four outpatient therapeutic programs in the Blantyre district of Malawi.


Clinical Trial Description

RUTF has successfully promoted recovery from severe wasting and widened treatment coverage. However, RUTF does not sufficiently promote linear growth, leaving many survivors of severe wasting at risk of persistent stunting. Stunting is associated with long-term effects like poor child development and an increased risk of non-communicable diseases in adults. High protein quantity and quality are known to stimulate linear growth; however, an RUTF with a higher protein quantity and quality than the standard RUTF has yet to be tested. The investigators hypothesize that the suboptimal linear growth in children surviving severe malnutrition can be improved by increasing the protein quantity and quality in the standard RUTF formulation. The investigators have designed a high protein quantity and quality RUTF that will be tested in a proof-of-concept quadruple-blind randomised controlled trial study design. The trial aims to compare the efficacy of higher-protein-RUTF and standard RUTF in improving markers of linear growth among 6-23 months old children with severe wasting. Children aged 6-23 months newly enrolled in outpatient treatment programs for severe wasting and without medical complications are eligible. They will be assigned to either increased protein RUTF or standard RUTF for eight weeks. The primary outcome is a change in insulin-like growth factor-1 (IGF- 1) after four weeks of treatment. IGF-1 is a hormone that is mechanistically linked with growth. Secondary outcomes include ponderal and linear growth changes from baseline measured at eight weeks and plasma amino acid profile at four weeks. Other secondary outcomes are the acceptability and safety of high protein RUTF compared to standard RUTF. These findings will help to determine the optimal protein composition of RUTF to promote linear growth when treating severe wasting in children. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05737472
Study type Interventional
Source The Hospital for Sick Children
Contact
Status Completed
Phase N/A
Start date November 14, 2022
Completion date August 23, 2023

See also
  Status Clinical Trial Phase
Completed NCT03360877 - Prevention of Nosocomial Infections (CleanKids) N/A
Completed NCT04715204 - Gastrointestinal Tolerance of Under-five Children With Severe Acute Malnutrition to ONS Compared to F-75/F-100 N/A
Not yet recruiting NCT06038071 - Family Mid-Upper Arm Circumference (MUAC) Follow-up After Recovery From Acute Malnutrition (MODAM-fMUAC) N/A
Not yet recruiting NCT06061484 - Modified Dosage for Severe Acute Malnutrition N/A
Completed NCT03666572 - Pilot of a Prebiotic and Probiotic Trial in Young Infants With Severe Acute Malnutrition Phase 2
Completed NCT05015257 - Effectiveness of Four Transition Dietary Regimens in the Hospital Management of Children With Kwashiorkor. N/A
Completed NCT05020847 - Effectiveness of Alternative Diets During the Stabilization Phase on Children With Complicated SAM N/A
Recruiting NCT06123390 - Evaluating RISQ System Implementation in Acutely Malnourished Children in Chad (CRIMSON) N/A
Completed NCT03370003 - Non-routine Use of Antibiotics (Amoxi-light)
Completed NCT03303131 - SAM: Discharge Based on the Use of a MUAC-based Criterion to N/A
Recruiting NCT06002438 - Eggs for Gut Health N/A
Terminated NCT05473234 - Azithromycin for Severe Acute Malnutrition in CMAM, Nigeria Phase 3
Completed NCT01613547 - The Effect of Routine Antibiotic Use in the Outpatient Treatment of Severely Malnourished Children Without Complications N/A
Completed NCT01331044 - Ready to Use Therapeutic Food (RUTF) in Severe Malnourished Children N/A
Completed NCT03094247 - Feeding Malnourished Children Different Types of Fatty Acids to Promote Neurocognitive Development N/A
Recruiting NCT04240990 - Development of a Diagnostic Prediction Score for Tuberculosis in Hospitalized Children With Severe Acute Malnutrition N/A
Completed NCT01958905 - Efficacy and Bio-availability of Artemether-Lumefantrine in Severely Malnourished Children N/A
Completed NCT03716115 - Therapeutic Approaches to Malnutrition Enteropathy Phase 2
Completed NCT01593969 - A Trial of n-3 PUFA-Enriched Ready to Use Therapeutic Food for Childhood Severe Malnutrition Phase 2
Completed NCT05891457 - Changes in Nerve Electro Physiologic Properties in Children Before and After Correction of Malnutrition N/A