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

Primary Purpose

Child Malnutrition, Infant Morbidity

Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Dietary Supplement: Nutrition supplement with RUTF or MNP
Sponsored by
Medecins Sans Frontieres, Spain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Child Malnutrition

Eligibility Criteria

6 Months - 59 Months (Child)All SexesAccepts Healthy Volunteers

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*

Sites / Locations

  • Kaabong Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Experimental: Ready to Use Terapeutic Food (RUTF)

Multi Micronutrient Powder (MNP)

no supplement

Arm Description

Outcomes

Primary Outcome Measures

"negative nutritional outcome" of a child
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
study disease: malaria, diarrhoea, and LRTI

Full Information

First Posted
December 20, 2011
Last Updated
June 29, 2015
Sponsor
Medecins Sans Frontieres, Spain
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1. Study Identification

Unique Protocol Identification Number
NCT01497236
Brief Title
Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection in Karamoja, Uganda
Acronym
MSF-nutcon03
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 Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medecins Sans Frontieres, Spain

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
similar to MSF-nutcon 03 : NCT01154803

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Malnutrition, Infant Morbidity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Ready to Use Terapeutic Food (RUTF)
Arm Type
Experimental
Arm Title
Multi Micronutrient Powder (MNP)
Arm Type
Experimental
Arm Title
no supplement
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary Supplement: Nutrition supplement with RUTF or MNP
Other Intervention Name(s)
Other Names:, RUTF: Nutriset, MNP: MixMe, DSM, Placebo: DSM
Intervention Description
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
Primary Outcome Measure Information:
Title
"negative nutritional outcome" of a child
Description
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
Time Frame
6 months follow-up
Secondary Outcome Measure Information:
Title
Number of new events of a study disease
Description
study disease: malaria, diarrhoea, and LRTI
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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*
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nuria Salse
Organizational Affiliation
MSF Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaabong Hospital
City
Kaabong
State/Province
Karamoja district
Country
Uganda

12. IPD Sharing Statement

Citations:
PubMed Identifier
26859481
Citation
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.
Results Reference
derived

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

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