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Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection in Karamoja, Uganda (MSF-nutcon03)

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ClinicalTrials.gov Identifier: NCT01497236
Recruitment Status : Completed
First Posted : December 22, 2011
Last Update Posted : June 30, 2015
Sponsor:
Information provided by (Responsible Party):
Nuria Salse, Medecins Sans Frontieres, Spain

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Child Malnutrition Infant Morbidity Dietary Supplement: Dietary Supplement: Nutrition supplement with RUTF or MNP Not Applicable

Detailed Description:
similar to MSF-nutcon 03 : NCT01154803

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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
Study Start Date : March 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental: Ready to Use Terapeutic Food (RUTF) Dietary Supplement: Dietary Supplement: Nutrition supplement with RUTF or MNP

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

Experimental: Multi Micronutrient Powder (MNP) Dietary Supplement: Dietary Supplement: Nutrition supplement with RUTF or MNP

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

No Intervention: no supplement



Primary Outcome Measures :
  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 Outcome Measures :
  1. Number of new events of a study disease [ Time Frame: 6 months ]
    study disease: malaria, diarrhoea, and LRTI



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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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*

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01497236


Locations
Uganda
Kaabong Hospital
Kaabong, Karamoja district, Uganda
Sponsors and Collaborators
Medecins Sans Frontieres, Spain
Investigators
Principal Investigator: Nuria Salse MSF Spain

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nuria Salse, Nutrition Advisor MSF Spain, Medecins Sans Frontieres, Spain
ClinicalTrials.gov Identifier: NCT01497236     History of Changes
Other Study ID Numbers: MSF-nutcon03
First Posted: December 22, 2011    Key Record Dates
Last Update Posted: June 30, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Malnutrition
Child Nutrition Disorders
Nutrition Disorders
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs