Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection

Medecins Sans Frontieres, Netherlands2,213 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

2,213

Conditions

Malnutrition Malaria Lower Respiratory Tract Infection Diarrhoea

Interventions

Ready to Use Therapeutic Food (RUTF)DIETARY_SUPPLEMENT

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)DIETARY_SUPPLEMENT

2 sachets / day for 14 days after an illness (diarrheoea, malaria, pneumonia)

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 59 Months

Medical Language ↔ Plain English

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\*

Locations (1)

Goronyo health clinic outpatient department

Goronyo, Sokoto State, Nigeria

Outcomes

Primary Outcomes

"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.

Time frame: 6 months follow-up

Secondary Outcomes

Number of new events of a study disease

study disease: malaria, diarrhoea, and LRTI

Time frame: 6 months

Data from ClinicalTrials.gov

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