NCT02077907

Comparison of Four Different Supplementary Foods in the Treatment of Moderate Acute Malnutrition (MAM) in Children in Sierra Leone: a Cluster-randomised, Controlled Clinical Effectiveness Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,147 (actual)
• Sponsor: Tufts University · Academic / Other
• Sex: All
• Age: 6 Months – 59 Months
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Moderate Acute Malnutrition (MAM)

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Super Cereal Plus (SC+)
DIETARY_SUPPLEMENT	Super Cereal (SC), fortified oil, sugar
DIETARY_SUPPLEMENT	Plumpy Sup
DIETARY_SUPPLEMENT	Corn Soy Blend 14 (CSB14) and fortified oil

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-07-01
• First posted: 2014-03-04
• Last updated: 2015-02-04