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Completed

NCT Number: NCT02085044

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

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).

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Key information

Conditions

Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

6 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Médecins Sans Frontières-OCG

Massakory, Chad

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • children between 6 months and 24 months of age

Exclusion criteria

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

Treatment and study plan

Ready-to-Used Supplement Food administration

Dietary Supplement

Other names: Plumpy 'doz

Primary outcomes

  1. Incidence of acute severe malnutrition

    Time frame: overall study time, 22 months

    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 )

  2. Mortality rate

    Time frame: overall study time 22 months

    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 )

Secondary outcomes

  1. Morbidity

    Time frame: overall study time 22 months

  2. Gain of mid-upper-arm circumference (MUAC) gain

    Time frame: 22 months

  3. Weight for Height gain

    Time frame: 22 months

Sponsors and collaborators

Lead sponsor

France Broillet

Other

Collaborators

  • Swiss Tropical & Public Health Institute

Registry information

Official study title

Non Randomized Controlled Intervention Study Comparing Two Interventions of Nutritional Supplement on Malnutrition, Health and Mortality in Children Aged 6 to 24 Month Hadjer-Lamis Region - Chad

Acronym: NRCI-ASPE

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 12, 2014
Registry last updated
Mar 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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