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Completed

NCT Number: NCT01497236

Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection in Karamoja, Uganda

The purpose of this study is to determine whether 14 days nutritional supplementation with Ready to use therapeutic Food (RUTF) or micronutrients alone to children having an infection will prevent malnutrition and reduce the frequency of morbidity.

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Key information

Conditions

Child Malnutrition Child Nutrition Disorders Infant Morbidity Nutrition Disorders Nutritional and Metabolic Diseases

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaabong Hospital

Kaabong, Karamoja District, Uganda

About this study

similar to MSF-nutcon 03 : NCT01154803

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 6 to 59 months of age
  • Not malnourished
  • Diagnosis of malaria and/or diarrhoea and/or LRTI
  • Intending to remain in area for the duration of the 6 month follow-up
  • Living within approximately 60 minutes walking distance from the clinic
  • Informed consent from a guardian*

Exclusion criteria

  • Child is exclusively breastfeeding
  • Child is severely malnourished
  • Presence of 'General Danger Signs'
  • Presence of severe disease (including severe malaria, severe LRTI, severe diarrhoea)
  • Needing hospitalisation for any reason
  • Known history of allergy to the nutritional supplementation
  • Having a sibling enrolled in the study*

Treatment and study plan

Dietary Supplement: Nutrition supplement with RUTF or MNP

Dietary Supplement

14 days nutritional supplementation with either

  • a fortified high quality food(RUTF), 1 sachet/day, 500 kcal and multi micronutrients
  • a multi micronutrient powder (MNP), 2 sachets per day, no calories, twice recommended daily intake
  • a placebo (to MNP), 2 sachets per day , no calories, no micronutrients, containing micronutrient carrier

Other names: Other Names:, RUTF: Nutriset, MNP: MixMe, DSM, Placebo: DSM

Primary outcomes

  1. "negative nutritional outcome" of a child

    Time frame: 6 months follow-up

    The incidence of a negative nutritional outcome will be defined in two different ways according to the baseline nutritional status.

    i) for children with no malnourishment at time of entry into study, "negative nutritional outcome" is defined as progression to moderate or severe malnourishment ii) for children with moderate malnourishment at time of entry into study, "negative nutritional outcome" is defined as loss of ³10% of baseline weight or progression to severe malnourishment, whichever is reached first

Secondary outcomes

  1. Number of new events of a study disease

    Time frame: 6 months

    study disease: malaria, diarrhoea, and LRTI

Sponsors and collaborators

Lead sponsor

Medecins Sans Frontieres, Spain

Other

Registry information

Official study title

Effectiveness of Nutritional Supplementation (RUTF and Multi Micronutrient) in Preventing Malnutrition in Children 6-59 Months With Infection (Malaria, Pneumonia, Diarrhoea), a Randomized Controlled Trial in Kaabong, Karamoja, Uganda

Acronym: MSF-nutcon03

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 22, 2011
Registry last updated
Jun 30, 2015

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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