NCT02071563

Brief Summary

This research will serve as a follow-up on the review of Title II commodities performed by the Food Aid Quality Review at Tufts University in October 2011. The study in Burkina Faso will test the relative effectiveness and cost effectiveness of four supplementary foods in the prevention of MAM and stunting in normal programmatic settings. The aims of this study are to:

  1. 1.To compare the effectiveness of four alternative supplementary food commodities in preventing stunting and wasting, and promoting linear growth in children 6 - 23 months in the context of a preventive supplementary feeding program in Burkina Faso.
  2. 2.To estimate the relative cost of implementing the supplementary feeding program using each commodity
  3. 3.To estimate the relative cost/effectiveness of implementing the program using each commodity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,039

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2013

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 26, 2014

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

October 24, 2017

Status Verified

October 1, 2017

Enrollment Period

2.8 years

First QC Date

September 23, 2013

Last Update Submit

October 20, 2017

Conditions

Child Malnutrition

Outcome Measures

Primary Outcomes (1)

  • Incidence of MAM and Stunting

    Primary outcomes to be measured are incidence of MAM and incidence of stunting during the 18 months of preventive supplementation (age 6 months to 23 months). Stunting will be defined as less than -2 SD of Height-for-Age Z-score and MAM will be defined as less than -2 SD Weight-for-Height (length) Z-score

    Monthly for 18 months

Study Arms (4)

CSB14

ACTIVE COMPARATOR

Isocaloric amount and cost-effectiveness of CSB14 (with whey protein concentrate and enhanced micronutrient profile), prepared with fortified vegetable oil (FVO).

Dietary Supplement: CSB14

RUSF1

ACTIVE COMPARATOR

Isocaloric amount and cost-effectiveness of Ready-to Use Supplementary Food 1(RUSF1), USAID's Lipid-Based Nutrient Supplement (LNS) product

Dietary Supplement: RUSF1

SC+

ACTIVE COMPARATOR

Isocaloric amount and cost-effectiveness of Supercereal Plus (SC+), the FBF used by WFP, which has an enhanced nutrient profile, dairy ingredient (non-fat dry milk), and oil already embedded into the flour

Dietary Supplement: SC+

CSB+

NO INTERVENTION

Isocaloric amount and cost-effectiveness of Supercereal/CSB+ prepared with FVO.

Interventions

CSB14DIETARY_SUPPLEMENT
CSB14
RUSF1DIETARY_SUPPLEMENT
RUSF1
SC+DIETARY_SUPPLEMENT
SC+

Eligibility Criteria

Age6 Months - 23 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Child enrolled in the ViM program to receive ration from a Food Distribution Point

You may not qualify if:

  • Children who are over 6 months of age when the study begins
  • Children receiving food rations from another organization (e.g. World Food Programme or UNICEF)
  • Beneficiary Mothers/Caretakers (Mothers/Caretakers of Children 6 -23 months old)
  • Beneficiary Mother/Caretaker whose child turns 6 months old and is enrolled in ViM program to receive ration during the study period
  • Subject who is voluntarily willing to participate and indicates by signing (or marking with a thumbprint) the consent form.
  • HNP who covers the catchment area of the FDPs
  • Subject who is voluntarily willing to participate by signing the consent form
  • Community Health Agents serving within the catchment area for the FDPs
  • Community Health Agents 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 ACDI/VOCA and Save the Children who are directly involved in the ViM program
  • PVO Staff members who joined too recently to have experience of the program change (new commodities)
  • Village elder/headmen in study commune
  • Village elder/headmen whose community is not involved in the feeding program
  • Store owner/market vendor in study communes who trades in the relevant products (food vendors)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Kaya, Sanmatenga, Burkina Faso

Location

Related Publications (5)

  • Cliffer IR, Naumova EN, Masters WA, Perumal N, Garanet F, Rogers BL. Peak timing of slowest growth velocity among young children coincides with highest ambient temperatures in Burkina Faso: a longitudinal study. Am J Clin Nutr. 2024 Feb;119(2):393-405. doi: 10.1016/j.ajcnut.2023.09.021. Epub 2023 Dec 29.

    PMID: 38309828DERIVED

  • Cliffer IR, Masters WA, Perumal N, Naumova EN, Zeba AN, Garanet F, Rogers BL. Monthly measurement of child lengths between 6 and 27 months of age in Burkina Faso reveals both chronic and episodic growth faltering. Am J Clin Nutr. 2022 Jan 11;115(1):94-104. doi: 10.1093/ajcn/nqab309.

    PMID: 34637506DERIVED

  • Shen Y, Cliffer IR, Suri DJ, Langlois BK, Vosti SA, Webb P, Rogers BL. Impact of stakeholder perspectives on cost-effectiveness estimates of four specialized nutritious foods for preventing stunting and wasting in children 6-23 months in Burkina Faso. Nutr J. 2020 Feb 27;19(1):20. doi: 10.1186/s12937-020-00535-x.

    PMID: 32106840DERIVED

  • Cliffer IR, Nikiema L, Langlois BK, Zeba AN, Shen Y, Lanou HB, Suri DJ, Garanet F, Chui K, Vosti S, Walton S, Rosenberg I, Webb P, Rogers BL. Cost-Effectiveness of 4 Specialized Nutritious Foods in the Prevention of Stunting and Wasting in Children Aged 6-23 Months in Burkina Faso: A Geographically Randomized Trial. Curr Dev Nutr. 2020 Jan 23;4(2):nzaa006. doi: 10.1093/cdn/nzaa006. eCollection 2020 Feb.

    PMID: 32072130DERIVED

  • Langlois BK, Cliffer IR, Nikiema L, Suri DJ, Garanet F, Shen Y, Zeba AN, Walton SM, Lanou HB, Webb P, Rogers BL. Factors that May Influence the Effectiveness of 4 Specialized Nutritious Foods in the Prevention of Stunting and Wasting in Children Aged 6-23 Months in Burkina Faso. Curr Dev Nutr. 2020 Jan 6;4(2):nzaa002. doi: 10.1093/cdn/nzaa002. eCollection 2020 Feb.

    PMID: 31998858DERIVED

MeSH Terms

Conditions

Child Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Beatrice L Rogers, PhD

    Tufts University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2013

First Posted

February 26, 2014

Study Start

March 1, 2014

Primary Completion

January 1, 2017

Study Completion

June 1, 2017

Last Updated

October 24, 2017

Record last verified: 2017-10

Locations

BU(1)