Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children 6-59 Months With Infection in Karamoja, Uganda (MSF-nutcon03)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Medecins Sans Frontieres, Spain
Sponsor:
Information provided by (Responsible Party):
Nuria Salse, Medecins Sans Frontieres, Spain
ClinicalTrials.gov Identifier:
NCT01497236
First received: December 20, 2011
Last updated: October 4, 2012
Last verified: October 2012
  Purpose

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 Intervention
Acute Malnutrition
Morbidity
Dietary Supplement: Dietary Supplement: Nutrition supplement with RUTF or MNP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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 Hospital. Karamoja, Uganda

Resource links provided by NLM:


Further study details as provided by Medecins Sans Frontieres, Spain:

Primary Outcome Measures:
  • "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



Secondary Outcome Measures:
  • Number of new events of a study disease [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    study disease: malaria, diarrhoea, and LRTI


Estimated Enrollment: 2200
Study Start Date: March 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

similar to MSF-nutcon 03 : NCT01154803

  Eligibility

Ages Eligible for Study:   6 Months to 59 Months
Genders Eligible for Study:   Both
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*
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01497236

Contacts
Contact: Nuria Salse Ubach 0034933046188 nuria.salse@barcelona.msf.org

Locations
Uganda
Kaabong Hospital Recruiting
Kaabong, Karamoja district, Uganda
Contact: James Kisambu, Dr    : +256 (0) 772 927 164    drkisambu@yahoo.com   
Sub-Investigator: James Kusambu, Dr         
Sponsors and Collaborators
Medecins Sans Frontieres, Spain
Investigators
Principal Investigator: Nuria Salse MSF Spain
  More Information

No publications provided

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
Study First Received: December 20, 2011
Last Updated: October 4, 2012
Health Authority: Uganda: National Council for Science and Technology

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

ClinicalTrials.gov processed this record on July 23, 2014