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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nuria Salse, Medecins Sans Frontieres, Spain
ClinicalTrials.gov Identifier:
NCT01497236
First received: December 20, 2011
Last updated: June 29, 2015
Last verified: June 2015

December 20, 2011
June 29, 2015
March 2011
October 2012   (final data collection date for primary outcome measure)
"negative nutritional outcome" of a child [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]

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

Same as current
Complete list of historical versions of study NCT01497236 on ClinicalTrials.gov Archive Site
Number of new events of a study disease [ Time Frame: 6 months ] [ Designated as safety issue: No ]
study disease: malaria, diarrhoea, and LRTI
Same as current
Not Provided
Not Provided
 
Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection in Karamoja, Uganda
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
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.
similar to MSF-nutcon 03 : NCT01154803
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Child Malnutrition
  • Infant Morbidity
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: Experimental: Ready to Use Terapeutic Food (RUTF)
    Intervention: Dietary Supplement: Dietary Supplement: Nutrition supplement with RUTF or MNP
  • Experimental: Multi Micronutrient Powder (MNP)
    Intervention: Dietary Supplement: Dietary Supplement: Nutrition supplement with RUTF or MNP
  • No Intervention: no supplement
van der Kam S, Roll S, Swarthout T, Edyegu-Otelu G, Matsumoto A, Kasujja FX, Casademont C, Shanks L, Salse-Ubach N. Effect of Short-Term Supplementation with Ready-to-Use Therapeutic Food or Micronutrients for Children after Illness for Prevention of Malnutrition: A Randomised Controlled Trial in Uganda. PLoS Med. 2016 Feb 9;13(2):e1001951. doi: 10.1371/journal.pmed.1001951. eCollection 2016 Feb.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2202
October 2012
October 2012   (final data collection date for primary outcome measure)

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*
Both
6 Months to 59 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Uganda
 
NCT01497236
MSF-nutcon03
Yes
Not Provided
Not Provided
Nuria Salse, Medecins Sans Frontieres, Spain
Medecins Sans Frontieres, Spain
Not Provided
Principal Investigator: Nuria Salse MSF Spain
Medecins Sans Frontieres, Spain
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP