Clinical trial NCT01154803: Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection
Official title: Effectiveness of Nutritional Supplementation (RUTF and Multi Micronutrient) in Preventing Malnutrition in Children 6-59 Months With Infection (Malaria, Pneumonia, Diarrhoea), a Randomized Controlled Trial in Nigeria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Malaria
Lower Respiratory Tract Infection
Diarrhoea
Keywords: Supplementation
RUTF
Micronutrients
Plumpynut
Mixme
sprinkles
convalescence
weight
morbidity
Lead sponsor: Medecins Sans Frontieres, Netherlands
Sponsor class: OTHER
First posted: 2010-07-01
Enrollment: 2213
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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\*

Primary outcomes:
measure: "negative nutritional outcome" of a child
timeFrame: 6 months follow-up
Secondary outcomes:
measure: Number of new events of a study disease
timeFrame: 6 months
Other outcomes:
Locations:
city: Goronyo
country: Nigeria
facility: Goronyo health clinic outpatient department
state: Sokoto
Study officials:
affiliation: Medecins Sans Frontieres Amsterdam
name: Saskia Kam van der, Ir
role: PRINCIPAL_INVESTIGATOR
References:
citation: van der Kam S, Salse-Ubach N, Roll S, Swarthout T, Gayton-Toyoshima S, Jiya NM, Matsumoto A, Shanks L. Effect of Short-Term Supplementation with Ready-to-Use Therapeutic Food or Micronutrients for Children after Illness for Prevention of Malnutrition: A Randomised Controlled Trial in Nigeria. PLoS Med. 2016 Feb 9;13(2):e1001952. doi: 10.1371/journal.pmed.1001952. eCollection 2016 Feb.