Clinical trial NCT01790048: Whey Permeate Study
Official title: Comparison of a Novel Ready-to-use Supplementary Food (RUSF) With Whey Permeate to Standard Peanut/Soy RUSF for the Treatment of Moderate Acute Malnutrition in Rural Malawian Children: a Randomised, Double-blinded, Clinical Effectiveness Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: MAM
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2013-02-12
Enrollment: 2259
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized, double-blinded, controlled clinical effectiveness trial of two supplementary foods in the treatment of MAM.

Specific Aim 1: Test the effectiveness of two supplementary foods, whey RUSF and soy RUSF, in the treatment of MAM in 6-59 month old children in a 12-week home-based supplementary feeding program.

Hypothesis: The proportion of children who recover receiving either soy or whey RUSF will differ by no more than three percent.

Detailed description: This will be a randomized, double-blinded, controlled clinical effectiveness trial assessing the treatment of moderate acute malnutrition (MAM) with one of two supplementary foods for a period of up to 12 weeks. The overall purpose of this research is to see if your child will grow and gain weight more rapidly using one of two peanut butter foods as he/she recovers from protein-energy malnutrition.

Subjects will be given a soy or dairy peanut butter food at their home. The peanut butter food has either small amounts of soya protein and minerals (iron, zinc) or whey powder and minerals added to them. Subjects will have enough food to feed the child for 2 weeks, and asked to return every 2 weeks to be weighed, measured and given more food. The parents of the subjects will be asked to feed their child this food until his/her weight has returned to what is considered normal for the child's height. Subjects will then return after 3, 6 and 12 months for a check-up. At these check-ups, he/she will be measured and examined.

The current standard of care is to allow the child to recover without food or with supplemental flour thus all participation is related to research. Participation in this study is expected to last 8-12 weeks of therapy with follow up in 12 months after completion of the therapy.

Eligibility criteria: Inclusion Criteria:

* Children with MAM defined as mid-upper-arm circumference, MUAC, ≤ 12.5 cm and \> 11.5 cm without bipedal edema.

Exclusion Criteria:

* Children simultaneously involved in another research trial or supplemental feeding program
* Children with developmentally delayed
* Children with a chronic debilitating illness such as cerebral palsy (not including HIV or TB)
* Children with a history of peanut or milk allergy
* Children will also be excluded if they had received therapy for acute malnutrition within one month prior to presentation.

Primary outcomes:
measure: Recovery From Moderate Acute Malnutrition (MAM)
timeFrame: 3 months
Secondary outcomes:
measure: Weight
timeFrame: 3 months
measure: Height
timeFrame: 3 months
measure: Mid-Upper-Arm Circumference (MUAC) Gain
timeFrame: 3 months
measure: Time to Graduation
timeFrame: 3 months
measure: Adverse Events
timeFrame: 3 months
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: Project Peanut Butter
Study officials:
affiliation: Washington University School of Medicine
name: Mark Manary, MD
role: PRINCIPAL_INVESTIGATOR
References:
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