Comparison of Four Different Supplementary Foods in the Treatment of Moderate Acute Malnutrition

NCT03146897 | Completed

• 1 other identifier: FAQR
• Study Type: interventional
• Target: 2,691
• Locations: 1 country
• Sites: 1

Brief Summary

The research seeks to determine the relative effectiveness and cost effectiveness of alternative supplementary foods in the treatment of moderate acute malnutrition (MAM) in normal program settings. The results of this study will guide decisions about what commodities to use in supplementary feeding programs in particular contexts and populations, and what factors need to be addressed to ensure maximum effectiveness in the treatment of moderate malnutrition. Tufts University, Washington University in St. Louis, School of Medicine, Sierra Leone Ministry of Health and Sanitation (MoHS), Project Peanut Butter, Caritas Bo, World Food Programme (WFP), and the United States Agency for International Development (USAID) are collaborating to conduct an assessment of the effectiveness, cost, and cost-effectiveness of food aid commodities in treating moderate acute malnutrition (MAM) in young children. The study comparison is based on a targeted food delivery to children 6-59 months who are screened for MAM. Study participants will receive one of four approximately isoenergetic test foods:

1. 1.Super Cereal Plus (SC+) with amylase
2. 2.Corn-soy Blend Plus (CSB+) and fortified vegetable oil
3. 3.Corn-soy Whey Blend (CSWB) and fortified vegetable oil (CSWB is a new product which is a modified version of CSB)
4. 4.Ready-to-use Supplementary Food (RUSF, lipid-based)

Conditions

Moderate Acute Malnutrition

Keywords

Food Aid, Malnutrition, RUSF, FBF, Supplementary Food

Outcome Measures

Primary Outcomes (3)

• Effectiveness assessed by recovery from MAM, defined as achieving mid-upper arm circumference (MUAC) ≥ 12.5 cm within the 12-week treatment period

  Graduation from MAM, defined as achieving mid-upper arm circumference (MUAC) ≥ 12.5 cm within the 12-week treatment period

  12 weeks

• Cost-Effectiveness

  Assess program costs among the four study arms including fixed, start-up and ongoing costs of food supplements, repackaging, transportation, storage, distribution, other clinical and SBCC programming activities, and caregivers' opportunity costs. Link these costs with the effectiveness outcomes to determine and compare the cost-effectiveness of using each supplement to treat MAM (e.g. Cost per Case of MAM graduated).

  12 weeks

• WHZ => -2 SD among children treated for up to 12 weeks or until reaching graduation based on MUAC whose WHZ was < -2 SD at enrollment

  Percent of children enrolled in MAM treatment whose WHZ =\> -2 SD (calculated based on height at enrollment and weight at graduation) at graduation based on MUAC or at 12 weeks of treatment, whichever is earliest, taking into consideration their WHZ at enrollment.

  12 weeks

Secondary Outcomes (6)

• Weight (g/kg/d)

  4 weeks

• MUAC (mm/d) gain within first 4 weeks

  4 weeks

• Change in weight-for-height Z score (WHZ) and height-for-age Z score (HAZ), height gain (mm/d), enrollment to discharge and 1,3,6 months post discharge

  6 months

• Time to graduation

  12 weeks

• Post-treatment growth status

  Up to 6 months after graduation/discharge

Study Arms (4)

Super Cereal Plus with amylase

ACTIVE COMPARATOR

Dietary Supplement: Supplementary Food

Corn-soy Blend Plus and Vegetable Oil

ACTIVE COMPARATOR

Dietary Supplement: Supplementary Food

Corn-soy Whey Blend and Vegetable Oil

ACTIVE COMPARATOR

Dietary Supplement: Supplementary Food

Ready-to-Use-Supplementary Food

ACTIVE COMPARATOR

Dietary Supplement: Supplementary Food

Interventions

Supplementary Food DIETARY_SUPPLEMENT

Supplementary food for treating MAM

Corn-soy Blend Plus and Vegetable Oil; Corn-soy Whey Blend and Vegetable Oil; Ready-to-Use-Supplementary Food; Super Cereal Plus with amylase

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child diagnosed with MAM based on MUAC and enrolled to receive a ration from a feeding site (i.e. enrolled in the SFP)

You may not qualify if:

• Children with bipedal oedema
• Children receiving food rations from another organization (e.g. USAID, WFP, UNICEF) for treatment of MAM
• Children who have previously been enrolled in the study (they are not eligible to be re-enrolled in the study but are still eligible to receive food)

Sponsors & Collaborators

• Tufts University: lead
• Washington University School of Medicine: collaborator
• Project Peanut Butter: collaborator
• Caritas Bo: collaborator
• Ministry of Health and Sanitation, Sierra Leone: collaborator
• United Nations World Food Programme (WFP): collaborator
• United States Agency for International Development (USAID): collaborator

Study Sites (1)

Stacy Griswold, MS

Pujehun, Sierra Leone

Location

Related Publications (2)

• Griswold SP, Langlois BK, Shen Y, Cliffer IR, Suri DJ, Walton S, Chui K, Rosenberg IH, Koroma AS, Wegner D, Hassan A, Manary MJ, Vosti SA, Webb P, Rogers BL. Effectiveness and cost-effectiveness of 4 supplementary foods for treating moderate acute malnutrition: results from a cluster-randomized intervention trial in Sierra Leone. Am J Clin Nutr. 2021 Sep 1;114(3):973-985. doi: 10.1093/ajcn/nqab140.

  PMID: 34020452 DERIVED

• Suri DJ, Potani I, Singh A, Griswold S, Wong WW, Langlois B, Shen Y, Chui KHK, Rosenberg IH, Webb P, Rogers BL. Body Composition Changes in Children during Treatment for Moderate Acute Malnutrition: Findings from a 4-Arm Cluster-Randomized Trial in Sierra Leone. J Nutr. 2021 Jul 1;151(7):2043-2050. doi: 10.1093/jn/nxab080.

  PMID: 33880554 DERIVED

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Beatrice Rogers, PhD

  Tufts University

  PRINCIPAL INVESTIGATOR

• Mark Manary, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Beatrice Lorge Rogers

Study Record Dates

• First Submitted: April 13, 2017
• First Posted: May 10, 2017
• Study Start: April 11, 2017
• Primary Completion: November 24, 2018
• Study Completion: November 24, 2018
• Last Updated: April 18, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

SI (1)