Moderate Acute Malnutrition (MAM) Clinical Trial
The objective of this study is to test and compare the effectiveness and cost-effectiveness
of four supplementary foods for the treatment of moderate acute malnutrition (MAM) in normal
programmatic settings in Sierra Leone. Study participants will receive one of four test
foods varying in energy and nutrient density as well as amounts provided.
1. Super Cereal Plus (SC+) at 800 kcal/d, 215 g/d (Control group)
2. Super Cereal (SC) and oil and sugar at 998 kcal/d - 200 g SC and 20 g oil and 20 g
sugar, per day
3. Corn-soy Blend 14 (CSB14) and oil at 978 kcal/day - 150 g CSB14 and 45 g oil, per day
4. Plumpy'Sup - 500 kcal/d, 92 g/d
This will be a prospective, randomised, controlled effectiveness trial.
Aims
1. (Impact) To compare the effectiveness of four supplementary foods in the treatment of
moderate acute malnutrition (MAM) in normal programmatic settings in Sierra Leone.
2. (Cost) To estimate the relative cost-effectiveness (marginal cost per child recovered
from MAM, relative to comparison group, SC+) of implementing the feeding program using
each commodity, taking into consideration costs of procurement/production and
distribution
3. (Process) To evaluate the determinants of effectiveness including: consumption
adherence, preparation compliance, targeting/sharing of supplement, food components and
preparation, adverse effects of foods, water contamination, hygiene and health
behaviors, SES, food security, perceived barriers
Outcomes
1. Recovery from MAM
1. Percent of children recovered from MAM (defined as achieving mid-upper arm
circumference (MUAC) ≥ 12.5 cm by 12 weeks once)
2. Percent default/non-response: children who do not recover after 12 weeks
3. Percent relapse: children who become MAM again within 6 months of recovery
2. Mean number of weeks to recovery
Hypothesis The children with MAM fed Super Cereal and oil and sugar, CSB14 and oil or
Plumpy'Sup will have similar recovery outcomes to those children fed Super Cereal Plus.
Null: The children with MAM fed Super Cereal and oil and sugar, CSB14 and oil or Plumpy'Sup
will have different recovery outcomes to those children fed Super Cereal Plus.
n/a
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02572258 -
Supplementary Food on Prevention of Moderate Malnutrition in Children
|
N/A | |
| Completed |
NCT01015950 -
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|
N/A |