Malnutrition, Malaria, Lower Respiratory Tract Infection, Diarrhoea
Conditions
Keywords
Supplementation, RUTF, Micronutrients, Plumpynut, Mixme, sprinkles, convalescence, weight, morbidity
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.
Interventions
DIETARY_SUPPLEMENTReady 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)
DIETARY_SUPPLEMENTMicronutrient Powder (MNP)
2 sachets / day for 14 days after an illness (diarrheoea, malaria, pneumonia)
Sponsors
Medecins Sans Frontieres, Netherlands
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
No
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\*
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
Nigeria
Outcome results
None listed