Clinical Trials Logo

Clinical Trial Summary

To test whether a ready-to-use therapeutic food (RUTF) enriched with polyunsaturated fatty acids (RUTF-P) is as effective for the treatment of severe acute malnutrition (SAM) as standard RUTF.


Clinical Trial Description

Since 2007, RUTF has been the recommended treatment for SAM. RUTF is not conducive to the growth of bacteria because of the low moisture content, does not require cooking, and has led to greater recovery rates than liquid milk formulations in direct comparisons. One expected benefit of the RUTF-P is improved outcomes due to the higher levels of essential fatty acids.

The essential fatty acid profile (i.e., the level of omega-3 and omega-6 fatty acids) of RUTF-P may have important implications for cognitive development of children, especially infants, with SAM who consume these foods as their sole dietary source for several weeks. In particular, an excess of omega-6 fatty acids (from sources such as peanut and corn oil) and a minimum of omega-3 fatty acids (from sources like flax) may fail to support optimal cognitive development and neural function.

In this prospective, double-blinded, randomized controlled clinical effectiveness trial, we will compare two RUTF products in the treatment of SAM to test the effects of the two different RUTF products on essential fatty acid status. ;


Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02053857
Study type Interventional
Source Washington University School of Medicine
Contact
Status Completed
Phase N/A
Start date February 2014
Completion date July 2014

See also
  Status Clinical Trial Phase
Completed NCT00429351 - Aromatic Amino Acid Metabolism in the Pathogenesis of Kwashiorkor
Completed NCT05020847 - Effectiveness of Alternative Diets During the Stabilization Phase on Children With Complicated SAM N/A
Completed NCT05015257 - Effectiveness of Four Transition Dietary Regimens in the Hospital Management of Children With Kwashiorkor. N/A
Completed NCT00069134 - Study of Antioxidants and Oxidants in Malnourished Children N/A
Completed NCT03520621 - The Role of Sulfur Amino Acids in Risk of Kwashiorkor
Completed NCT01529125 - Safety and Metabolic Study of Highly Active Antiretroviral Therapy (HAART) in Malnourished Children With HIV N/A
Completed NCT02413905 - Characterizing the Gut Microbiota Alteration Associated With Severe Acute Malnutrition N/A
Withdrawn NCT01395381 - Effectiveness of Oral Albendazole in the Treatment of Severe Acute Malnutrition N/A
Recruiting NCT06154174 - Choline to Improve Malnutrition and Enhance Cognition N/A
Completed NCT01000298 - Effectiveness of Oral Antibiotics in the Treatment of Severe Acute Malnutrition N/A
Completed NCT01790815 - Mothers Understand And Can do it - Mid Upper Arm Circumference Screening for Malnutrition Performed by Mothers N/A
Completed NCT05009823 - Dietary Rehabilitation in Severely Acutely Malnourished Children