Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection

Medecins Sans Frontieres, Netherlands

Status: Completed

Conditions: Malnutrition; Lower Respiratory Tract Infection; Malaria; Diarrhoea

Treatments: Dietary Supplement: Micronutrient Powder (MNP); Dietary Supplement: Ready to Use Therapeutic Food (RUTF)

Study type: Interventional

Funder types: Other

Identifiers

NCT01154803

MSF-nutcon02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,213 patients

Sex: All

Ages: 6 to 59 months old

Volunteers: No Healthy Volunteers

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*

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,213 participants in 3 patient groups

Ready to Use Therapeutic Food (RUTF)

Experimental group

Description:

500 kcal /day for 2 weeks

Treatment:

Dietary Supplement: Ready to Use Therapeutic Food (RUTF)

Micronutrient Powder (MNP)

Experimental group

Description:

2 x 1 g sachets micronutrients /day for 2 weeks

Treatment:

Dietary Supplement: Micronutrient Powder (MNP)

no supplement

No Intervention group

Description:

no supplementation