Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection
NCT ID: NCT01154803
Last Updated: 2013-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
2213 participants
INTERVENTIONAL
2012-02-29
2013-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Ready to Use Therapeutic Food (RUTF)
500 kcal /day for 2 weeks
Ready to Use Therapeutic Food (RUTF)
1 sachet/day, 500 kcal and multi micronutrients (fortified high quality food(RUTF),for 2 weeks after an illness (malaria, diarrhoea, pneumonia)
Micronutrient Powder (MNP)
2 x 1 g sachets micronutrients /day for 2 weeks
Micronutrient Powder (MNP)
2 sachets / day for 14 days after an illness (diarrheoea, malaria, pneumonia)
no supplement
no supplementation
No interventions assigned to this group
Interventions
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Ready to Use Therapeutic Food (RUTF)
1 sachet/day, 500 kcal and multi micronutrients (fortified high quality food(RUTF),for 2 weeks after an illness (malaria, diarrhoea, pneumonia)
Micronutrient Powder (MNP)
2 sachets / day for 14 days after an illness (diarrheoea, malaria, pneumonia)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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\*
6 Months
59 Months
ALL
No
Sponsors
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Medecins Sans Frontieres, Netherlands
OTHER
Responsible Party
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Saskia van der Kam
Ir
Principal Investigators
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Saskia Kam van der, Ir
Role: PRINCIPAL_INVESTIGATOR
Medecins Sans Frontieres Amsterdam
Locations
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Goronyo health clinic outpatient department
Goronyo, Sokoto State, Nigeria
Countries
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References
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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.
Other Identifiers
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MSF-nutcon02
Identifier Type: -
Identifier Source: org_study_id