Clinical trial NCT00890695: Effectiveness of Supplementary Feeding During Infection Among Moderately Malnourished Children
Official title: Randomized Controlled Trial of an Outpatient Strategy of Ready to Use Supplementary Food (RUSF) Among Moderately Malnourished Children With Acute Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Malnutrition
Infection
Keywords: supplementary feeding
moderate malnutrition
acute infection
developing country
children
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2009-04-30
Enrollment: 64
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label randomised trial of nutrition products
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether an outpatient-based strategy of short-term, ready to use supplementary food (RUSF) among moderately malnourished children with acute infections achieves greater improvement in anthropometric measurements of wasting than usual diet.

Detailed description: Under nutrition is a contributing factor to at least a third of child deaths. Whilst severe malnutrition has the highest mortality risk, most malnutrition-related deaths are thought to be related to mild-moderate malnutrition.This is because moderate malnutrition is common, it directly increases the risk of death from common infectious diseases and may progress to severe malnutrition.

Malnutrition may arise from poverty, food insecurity or inadequate nutrition being offered, and may begin early in life. Malnutrition is exacerbated by the multiple effects of infectious diseases such as gastroenteritis, pneumonia, malaria or HIV. All these common infections are associated with net protein loss with diversion of essential amino acids to producing acute phase and immune response proteins. Fever is associated with an increased resting energy expenditure of 7 to 13% per degree Centigrade. Activation of inflammatory cascades also causes reduced appetite and loss of lean tissue and fat. Acute infection is therefore associated with growth faltering, resulting in a vicious cycle. Acute infection is therefore a potential target for intervention to interrupt the vicious cycle between malnutrition and infection in children.

This study aims to evaluate a strategy of giving short-term RUSF as a supplement to usual diet at home, without daily observed feeding, administered through existing health services at Kilifi District Hospital, Kenya. RUSF has a very low moisture content and is essentially a lipid-enveloped paste, it is microbiologically stable with a long shelf life at tropical temperatures and preserves delicate micronutrients such as vitamin A.

Eligibility criteria: Inclusion Criteria:

* Age 6 months to 5 years
* Mid-upper arm circumference (MUAC) less than 12.5 cm
* Resident in the Kilifi demographic surveillance (DSS) area
* Presentation with acute (\<5 days) illness including respiratory infection, malaria, diarrhoeal disease or other acute infection.
* If admitted, admission of \<5 days, recruited at discharge.

Exclusion Criteria:

* Severe malnutrition (WHZ score \< -3 or Kwashiorkor)
* Requiring admission to hospital in the opinion of clinician
* Known allergy to maize, soya, sorghum, milk or any RUSF components.
* Consent declined
* Underlying condition precluding assessment or inclusion
* Any other reason why the consenting investigator thinks it is not appropriate for them to take part.

Primary outcomes:
measure: Weight for Height z Score at 4 Weeks
timeFrame: between enrolment and 4 weeks
Secondary outcomes:
measure: WHZ Score at 3 Months
timeFrame: between enrolment and 3 months
measure: MUAC for Age Z Score at 3 Months
timeFrame: between enrolment and 4 weeks and at 3 months
measure: Development of Severe Malnutrition (WHZ Score <-3 and/or Kwashiorkor)
timeFrame: at 4 weeks and 3 months
measure: Anemia (Hb <9.3g/dl)
timeFrame: at 4 weeks
measure: Hospital Admission or Death
timeFrame: from enrolment to 3 months
Other outcomes:
Locations:
city: Kilifi
country: Kenya
facility: Kemri Wellcome Trust Research Programme
state: Coast Province
city: Kilifi
country: Kenya
facility: Kilifi District Hospital- OPD
state: Coast
Study officials:
affiliation: KEMRI-Wellcome Trust Collaborative Research Program
name: James A Berkley
role: PRINCIPAL_INVESTIGATOR
References: