Child Malnutrition, Infant Morbidity
Conditions
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
Interventions
DIETARY_SUPPLEMENTDietary 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
Sponsors
Medecins Sans Frontieres, Spain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 59 Months
Healthy volunteers
Yes
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\*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| negative nutritional outcome of a child | 6 months follow-up | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of new events of a study disease | 6 months | study disease: malaria, diarrhoea, and LRTI |
Countries
Uganda
Outcome results
None listed