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

Not Applicable

Terminated

• Conditions: Moderate Acute Malnutrition (MAM)
• Interventions: Dietary Supplement: Super Cereal Plus (SC+); Dietary Supplement: Super Cereal (SC), fortified oil, sugar; Dietary Supplement: Corn Soy Blend 14 (CSB14) and fortified oil; Dietary Supplement: Plumpy Sup

• Registration Number: NCT02077907
• Lead Sponsor: Tufts University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-02-28
• Study First Submitted QC: 2014-03-03
• Study First Posted: 2014-03-04
• Primary Completion: 2014-07
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-02
• Last Update Posted: 2015-02-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1147

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Super Cereal Plus (SC+)	Super Cereal Plus (SC+)	800 kcal/d, 215 g/d Current protocol for treating MAM is supplemental food distribution, often providing a fortified blended food (FBF) that requires cooking. In Sierra Leone, their FBF standard is Super Cereal Plus.
Super Cereal (SC) and oil and sugar	Super Cereal (SC), fortified oil, sugar	200 g SC and 20 g fortified oil and 15 g sugar, per day Fortified blended food (FBF) Fortified Oil with Vitamins A \& D
Corn Soy Blend 14 (CSB14) and fortified oil	Corn Soy Blend 14 (CSB14) and fortified oil	978 kcal/day - 150 g CSB14 and 45 g oil, per day Fortified blended food (FBF) Fortified Oil with Vitamins A \& D
Plumpy'Sup	Plumpy Sup	500 kcal/d, 92 g/d Ready-to-Use Supplementary Food (RUSF)

Primary Outcome Measures

Name	Time	Method
Recovery from MAM	12 weeks	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

Secondary Outcome Measures

Name	Time	Method
Change in Growth rates	12 weeks	Subjects will return to clinic every 2 weeks until MUAC of 12.5 cm is reached or until 12 weeks has elapsed. Follow-up recovery will then be measured at 6 months. At each clinic visit growth will be measured.
Duration of treatment	12 weeks	Subjects will return to clinic every 2 weeks until MUAC of 12.5 cm is reached or until 12 weeks has elapsed. Follow-up recovery will then be measured at 6 months. Time to achieve MUAC of 12.5 cm will be documented.
Cost estimates for participation	12 weeks	Average cost of treatment will be measured per participant, this includes intervention costs and any medical costs needed by participants. The study costs no money to participants.
Default reason	12 weeks	If a child defaults, then the reason will be an outcome measure. Reasons to default include loss to follow-up (the child will be attempted to be contacted 3 times prior to being considered lost), death, or he/she enters into the inpatient clinic.
Change in recovery status after 12 weeks	6 months	Any changes in recovery will be measured at 6 months at follow-up visits