Effectiveness of Supplementary Feeding During Infection Among Moderately Malnourished Children

NCT ID: NCT00890695

Last Updated: 2017-08-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2009-11-30

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.

Conditions

Malnutrition; Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ready to use supplementary food (RUSF)

The RUSF intervention consists of a food paste made of maize, soya, sorghum, vegetable oil, sugar, dried skim milk and vitamin/mineral premix, prepared by VALID Nutrition in collaboration with Insta Products, Kenya in accordance with composition specified by the latest WHO expert consultation in 2008. Children in the intervention arm receive 4 weeks supply of RUSF. The amount supplied is based on the child's weight to give energy supplement of 100kcal per kg per day, equivalent to 25g RUSF per kg per day.

Group Type: ACTIVE_COMPARATOR

Ready to use supplementary food (RUSF)

Intervention Type: DIETARY_SUPPLEMENT

It is a strategy of detection of moderate malnutrition and providing advice and short term provision of a standard formulation of ready to use supplementary food (RUSF) for 4 weeks with appropriate counseling on its use.The amount supplied will be based on the child's weight; 100kcal per kg per day which is equivalent to 25g RUSF per kg per day.

Normal diet (standard of care)

For equity, parents or guardians of children in the usual diet arm will be given 2 bags of maize meal(4Kg) for family consumption instead of RUSF. All parents and carers in both arms will also receive standard nutritional advice as specified in the current WHO IMCI handbook.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ready to use supplementary food (RUSF)

It is a strategy of detection of moderate malnutrition and providing advice and short term provision of a standard formulation of ready to use supplementary food (RUSF) for 4 weeks with appropriate counseling on its use.The amount supplied will be based on the child's weight; 100kcal per kg per day which is equivalent to 25g RUSF per kg per day.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

RUSF

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

James Berkley

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James A Berkley

Role: PRINCIPAL_INVESTIGATOR

KEMRI-Wellcome Trust Collaborative Research Program

Locations

Kemri Wellcome Trust Research Programme

Kilifi, Coast Province, Kenya

Kilifi District Hospital- OPD

Kilifi, Coast, Kenya

Countries

Kenya

Other Identifiers

SSC 1415

Identifier Type: -

Identifier Source: org_study_id