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

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

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

Sponsors & Collaborators

• Washington University School of Medicine

  collaborator OTHER

• Project Peanut Butter

  collaborator OTHER

• United Nations World Food Programme (WFP)

  collaborator OTHER

• United States Agency for International Development (USAID)

  collaborator FED

• Tufts University

  lead OTHER

Principal Investigators

• Mark Manary, MD · Washington University School of Medicine

• Beatrice Rogers, PhD · Tufts University, Friedman School of Nutrition

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

59 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-01-31

Primary Completion

2014-07-31