Non Randomized Controlled Intervention Study Comparing Two Interventions of Nutritional Supplement on Malnutrition, Health and Mortality

NCT02085044 | Completed Phase 4

• 1 other identifier: Médecins Sans Frontières-OCG
• Study Type: interventional
• Target: 5,700
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis for the study is that 12 months of a Ready-To-Use Supplementary Food (RUSF) distributions have a greater impact on children's health than the standard RUSF distributions during the hunger gap period (june to september). We estimated that the 12 month RUSF will decrease the incidence of severe acute malnutrition by 33% compared to an administration only during the hunger gap period (4 month a year).

Conditions

Malnutrition

Keywords

malnutrition; children's health; prevention; ready-to-use supplementary food; lipid based nutrient supplement; chad; children

Outcome Measures

Primary Outcomes (2)

• Incidence of acute severe malnutrition

  Incidence of acute severe malnutrition will be assessed for the overall 2 years. Estimation if incidence will include children from their entry in the study to their exit of study (disharge as 24 months, dead of Lost of follow up )

  overall study time, 22 months

• Mortality rate

  Mortality will be assessed for the overall 2 years. Estimation will include children from their entry in the study to their exit of study (disharge as 24 months, dead of Lost of follow up )

  overall study time 22 months

Secondary Outcomes (3)

• Morbidity

  overall study time 22 months

• Gain of mid-upper-arm circumference (MUAC) gain

  22 months

• Weight for Height gain

  22 months

Study Arms (2)

12 months RUSF

EXPERIMENTAL

Children between 6 to 24 months received ready-to-used supplementary food every months during the whole year.

Dietary Supplement: Ready-to-Used Supplement Food administration

4 months RUSF

ACTIVE COMPARATOR

children between 6 to 24 months of one zone received a ready-to-used supplement food during the 4 months of the hunger gap period (june to september)

Dietary Supplement: Ready-to-Used Supplement Food administration

Interventions

Ready-to-Used Supplement Food administration DIETARY_SUPPLEMENT

Also known as: Plumpy 'doz

12 months RUSF; 4 months RUSF

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• children between 6 months and 24 months of age

You may not qualify if:

• children who can 't swallow
• children from parents who does not want to be in the study

Sponsors & Collaborators

• France Broillet: lead
• Swiss Tropical & Public Health Institute: collaborator

Study Sites (1)

Médecins Sans Frontières-OCG

Massakory, Chad

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Annick Antierens

  Medecins Sans Frontieres, Netherlands

  STUDY CHAIR

• France Broillet

  Medecins Sans Frontieres, Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chargé de recherche operationnelle

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: March 12, 2014
• Study Start: February 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 12, 2014

Record last verified: 2013-10

Locations

CH (1)