Equivalency trial of a locally produced alternative ready-to-use therapeutic food (RUTF) in Ghana
Not Applicable
Completed
- Conditions
- Acute malnutrition as defined by weight for height z-score (WHZ) < -2, Mid-Upper Arm Circumference (MUAC) <12.5 cm, or bipedal edemaNutritional, Metabolic, EndocrineMalnutrition
- Registration Number
- ISRCTN14788669
- Lead Sponsor
- Washington University School of Medicine
- Brief Summary
2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31189698 results (added 03/04/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1270
Inclusion Criteria
Children aged 6-59 months with WHZ < -2, MUAC <12.5 cm, or bipedal edema
Exclusion Criteria
1. Children currently involved in another research trial or feeding program
2. Developmentally delayed
3. Chronic debilitating illness (such as cerebral palsy)
4. History of peanut or milk allergy
5. Serious adverse effects to the study food (such as an allergic reaction)
6. Received therapy for acute malnutrition within one month prior to presentation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Mid-upper arm circumference, measured with a standard insertion tape to the nearest 0.1 cm every two weeks until recovery<br> 2. Weight for length z-score (weight measured using an electronic scale to the nearest 5 g, length measured to the nearest 0.1 cm using a rigid length board), measured every two weeks until recovery<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Other anthropometric measures (weight measured using an electronic scale to the nearest 5 g, length measured to the nearest 0.1 cm using a rigid length board), measured every two weeks until recovery<br> 2. Adverse symptoms, such as stomach pain, vomiting, diarrhea, rash or fever, measured every two weeks until recovery<br>