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
NCT ID: NCT02077907
Last Updated: 2015-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
1147 participants
INTERVENTIONAL
2014-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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 Plus (SC+)
Super Cereal (SC) and oil and 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
Super Cereal (SC), fortified oil, sugar
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
Corn Soy Blend 14 (CSB14) and fortified oil
Plumpy'Sup
500 kcal/d, 92 g/d
Ready-to-Use Supplementary Food (RUSF)
Plumpy Sup
Interventions
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Super Cereal Plus (SC+)
Super Cereal (SC), fortified oil, sugar
Plumpy Sup
Corn Soy Blend 14 (CSB14) and fortified oil
Eligibility Criteria
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Inclusion Criteria
* Beneficiary Mother/Caretaker has no age restrictions for inclusion (Note: Mothers/caretakers will be asked to participate regardless of age and consented appropriately; it is possible some mothers may be minors)
* Subject who is voluntarily willing to participate and indicates by signing (or marking with a thumbprint) the consent form.
* Community Health Volunteers \& Health Development Committee Members serving within the catchment area for the PHUs
* Community Health Volunteers that have been present during the study period
* Subject who is voluntarily willing to participate and indicates by signing the consent form
* All staff members from Project Peanut Butter and the PHU who are directly involved in the feeding program
* Village elder/headmen in study commune
Exclusion Criteria
* Children receiving food rations from another organization (e.g. USAID or UNICEF)
Beneficiary Mothers/Caretakers (Mothers/Caretakers of Children 6 months to 59 months old)
• Beneficiary Mothers/Caretakers who participate in an interview, observation or FGD once for this study will not be eligible again for participation
* Staff members who joined too recently to have experience of the program change (new commodities)
* Village elder/headmen whose community is not involved in the feeding program
6 Months
59 Months
ALL
Yes
Sponsors
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Washington University School of Medicine
OTHER
Project Peanut Butter
OTHER
United Nations World Food Programme (WFP)
OTHER
United States Agency for International Development (USAID)
FED
Tufts University
OTHER
Responsible Party
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Principal Investigators
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Mark Manary, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Beatrice Rogers, PhD
Role: PRINCIPAL_INVESTIGATOR
Tufts University, Friedman School of Nutrition
Other Identifiers
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USAID
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
AID-016-Sierra Leone
Identifier Type: -
Identifier Source: org_study_id
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