Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection
Primary Purpose
Malnutrition, Malaria, Lower Respiratory Tract Infection
Status
Completed
Phase
Not Applicable
Locations
Nigeria
Study Type
Interventional
Intervention
Ready to Use Therapeutic Food (RUTF)
Micronutrient Powder (MNP)
Sponsored by
About this trial
This is an interventional prevention trial for Malnutrition focused on measuring Supplementation, RUTF, Micronutrients, Plumpynut, Mixme, sprinkles, convalescence, weight, morbidity
Eligibility Criteria
Inclusion Criteria:
- 6 to 59 months of age
- Not malnourished or moderately acutely malnourished children
- 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
- Goronyo health clinic outpatient department
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Ready to Use Therapeutic Food (RUTF)
Micronutrient Powder (MNP)
no supplement
Arm Description
500 kcal /day for 2 weeks
2 x 1 g sachets micronutrients /day for 2 weeks
no supplementation
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
NCT ID
NCT01154803
First Posted
June 30, 2010
Last Updated
October 15, 2013
Sponsor
Medecins Sans Frontieres, Netherlands
1. Study Identification
Unique Protocol Identification Number
NCT01154803
Brief Title
Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection
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 Nigeria
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medecins Sans Frontieres, Netherlands
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
Anorexia due to infection might lead to weight loss. In many settings total recovery is problematic what might result in a permanent lower weight. A short period high quality food supplementation could improve weight gain after an infection.
A complete high quality food will be tested, but also micronutrients alone as there is no information on what children with an infection exactly need as a supplement.
Children aged 6-59 months presenting with diarrhoea, malaria or lower respiratory tract infection (LRTI) are provided for 2 weeks with
RUTF supplement (Plumpynut®) of 500 kcal/day
Multi-micronutrient powder (MNP)
Placebo to MNP
The followup period is 6 months. Anthropometric indicators and morbidity are assessed monthly. Participants are invited to attend the study clinic if any signs of disease are noticed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Malaria, Lower Respiratory Tract Infection, Diarrhoea
Keywords
Supplementation, RUTF, Micronutrients, Plumpynut, Mixme, sprinkles, convalescence, weight, morbidity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2213 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ready to Use Therapeutic Food (RUTF)
Arm Type
Experimental
Arm Description
500 kcal /day for 2 weeks
Arm Title
Micronutrient Powder (MNP)
Arm Type
Experimental
Arm Description
2 x 1 g sachets micronutrients /day for 2 weeks
Arm Title
no supplement
Arm Type
No Intervention
Arm Description
no supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
Ready to Use Therapeutic Food (RUTF)
Other Intervention Name(s)
RUTF: Nutriset
Intervention Description
1 sachet/day, 500 kcal and multi micronutrients (fortified high quality food(RUTF),for 2 weeks after an illness (malaria, diarrhoea, pneumonia)
Intervention Type
Dietary Supplement
Intervention Name(s)
Micronutrient Powder (MNP)
Other Intervention Name(s)
MNP: DSM
Intervention Description
2 sachets / day for 14 days after an illness (diarrheoea, malaria, pneumonia)
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
No
Eligibility Criteria
Inclusion Criteria:
6 to 59 months of age
Not malnourished or moderately acutely malnourished children
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
Saskia Kam van der, Ir
Organizational Affiliation
Medecins Sans Frontieres Amsterdam
Official's Role
Principal Investigator
Facility Information:
Facility Name
Goronyo health clinic outpatient department
City
Goronyo
State/Province
Sokoto
Country
Nigeria
12. IPD Sharing Statement
Citations:
PubMed Identifier
26859559
Citation
van der Kam S, Salse-Ubach N, Roll S, Swarthout T, Gayton-Toyoshima S, Jiya NM, Matsumoto A, Shanks L. 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 Nigeria. PLoS Med. 2016 Feb 9;13(2):e1001952. doi: 10.1371/journal.pmed.1001952. eCollection 2016 Feb.
Results Reference
derived
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Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection
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