NCT01828814

Brief Summary

Options for large-scale preventive distributions include fortified blended flours, ready-to-use foods and direct cash transfer either alone or in combination with family protective rations. Finding the most appropriate strategy is essential to prevent child malnutrition in countries like Niger with annual hunger gaps. Here, the investigators compare different preventive strategies on the incidence of acute malnutrition among children 6 to 23 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7,836

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2011

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

Study Start

First participant enrolled

July 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 11, 2013

Completed
Last Updated

April 28, 2017

Status Verified

April 1, 2017

Enrollment Period

1.3 years

First QC Date

March 4, 2013

Last Update Submit

April 27, 2017

Conditions

Malnutrition

Keywords

pediatricsReady-to-use Supplementary Foodcorn soy blendcash transferprevention of malnutritionNiger

Outcome Measures

Primary Outcomes (1)

  • Incidence of severe acute malnutrition

    Severe acute malnutrition was defined as : Weight for Height Z-score (WHO Standards 2006)\< -3 and/or mid-upper arm circumference (MUAC) \< 115mm and/or bipedal oedema. MUAC was measured at the midpoint of a child's left arm with a plastic measuring tape with a precision of 1 mm. These indicators were evaluated monthly during the entire follow-up (15 months).

    15 months

Secondary Outcomes (1)

  • Mortality

    duration of follow-up (15 months)

Study Arms (7)

RUSF (500kcal/day) and cash transfer

Monthly distributions of Ready-to-use Supplementary Food (RUSF) 500kcal per day associated with cash transfer during hunger gap (5 months) then RUSF 500kcal/day for 10 months

Super Cereal Plus (SC+)

Monthly distributions of SC+ 800kcal per day during hunger gaps (5 months twice) and SC+ 400kcal per day in-between (5 months)

RUSF

Monthly distributions of Ready-to-use Supplementary Food (RUSF) 500kcal per day during hunger gaps (5 months twice) and RUSF 250kcal per day in-between (5 months)

RUSF (250kcal/day) and cash transfer

Monthly distributions of Ready-to-use Supplementary Food (RUSF) 250kcal per day associated with cash transfer during hunger gap (5 months) then RUSF 250kcal/day for 10 months

SC+ and cash transfer

Monthly distributions of Super Cereal Plus (SC+) 800 kcal per day associated with cash transfer during hunger gap (5 months)

SC+ and household ration

Monthly distributions of Super Cereal Plus (SC+) 800 kcal per day associated with food ration for household support during hunger gap (5 months)

Cash transfer

Monthly distributions of cash transfer only during hunger gap (5 months)

Eligibility Criteria

Age6 Months - 24 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children 6 to 24 months

You may qualify if:

  • resident in selected villages
  • height between 60 and 80 cm.

You may not qualify if:

  • refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Villages

Madarounfa, Maradi Region, Niger

Location

Related Publications (2)

  • Sayyad-Neerkorn J, Langendorf C, Roederer T, Doyon S, Mamaty AA, Woi-Messe L, Manzo ML, Harouna S, de Pee S, Grais RF. Preventive Effects of Long-Term Supplementation with 2 Nutritious Food Supplements in Young Children in Niger. J Nutr. 2015 Nov;145(11):2596-603. doi: 10.3945/jn.115.213157. Epub 2015 Sep 30.

    PMID: 26423742DERIVED

  • Langendorf C, Roederer T, de Pee S, Brown D, Doyon S, Mamaty AA, Toure LW, Manzo ML, Grais RF. Preventing acute malnutrition among young children in crises: a prospective intervention study in Niger. PLoS Med. 2014 Sep 2;11(9):e1001714. doi: 10.1371/journal.pmed.1001714. eCollection 2014 Sep.

    PMID: 25180584DERIVED

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Céline Langendorf, MPH

    Epicentre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2013

First Posted

April 11, 2013

Study Start

July 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

April 28, 2017

Record last verified: 2017-04

Locations

NI(1)