Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection

Not Applicable

Completed

• Conditions: Malnutrition; Malaria; Lower Respiratory Tract Infection; Diarrhoea
• Interventions: Dietary Supplement: Ready to Use Therapeutic Food (RUTF); Dietary Supplement: Micronutrient Powder (MNP)

• Registration Number: NCT01154803
• Lead Sponsor: Medecins Sans Frontieres, Netherlands

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.

Study Timeline

• Study First Submitted: 2010-06-30
• Study First Submitted QC: 2010-06-30
• Study First Posted: 2010-07-01
• Study Start: 2012-02
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-15
• Last Update Posted: 2013-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2213

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*

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ready to Use Therapeutic Food (RUTF)	Ready to Use Therapeutic Food (RUTF)	500 kcal /day for 2 weeks
Micronutrient Powder (MNP)	Micronutrient Powder (MNP)	2 x 1 g sachets micronutrients /day for 2 weeks

Primary Outcome Measures

Name	Time	Method
"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 Outcome Measures

Name	Time	Method
Number of new events of a study disease	6 months	study disease: malaria, diarrhoea, and LRTI

Trial Locations

Locations (1)

Goronyo health clinic outpatient department; 🇳🇬 Goronyo, Sokoto, Nigeria