Effectiveness of Supplementary Feeding During Infection Among Moderately Malnourished Children

NCT00890695 | Terminated Results

• 1 other identifier: SSC 1415
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

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.

Conditions

Malnutrition; Infection

Keywords

supplementary feeding; moderate malnutrition; acute infection; developing country; children

Outcome Measures

Primary Outcomes (1)

• Weight for Height z Score at 4 Weeks

  The primary endpoint is weight for height z scores (WHZ), calculated from weight and height measures with reference to the WHO growth standards 2006. WHZ is a measure of wasting and acute malnutrition. A WHZ of zero is the median value of the reference population. Negative scores indicate undernutrition. Moderate and severe acute malnutrition are defined as WHZ\<-2 and \<-3 respectively. These correspond to 2 and 3 standard deviations below the reference median. Of all the anthropometric measures in regular use, WHZ and mid upper arm circumference (MUAC) have the strongest associations with infectious disease incidence and risk of death. WHZ is more appropriate than Weight for Age (WAZ), which is normally used in growth monitoring, because WAZ measures a combination of wasting and stunting (chronic malnutrition). Stunting is unlikely to be affected by short term intervention. WHZ is assessed by anthropometry, following WHO guidelines.

  between enrolment and 4 weeks

Secondary Outcomes (5)

• WHZ Score at 3 Months

  between enrolment and 3 months

• MUAC for Age Z Score at 3 Months

  between enrolment and 4 weeks and at 3 months

• Development of Severe Malnutrition (WHZ Score <-3 and/or Kwashiorkor)

  at 4 weeks and 3 months

• Anemia (Hb <9.3g/dl)

  at 4 weeks

• Hospital Admission or Death

  from enrolment to 3 months

Study Arms (2)

Ready to use supplementary food (RUSF)

ACTIVE COMPARATOR

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.

Dietary Supplement: Ready to use supplementary food (RUSF)

Normal diet (standard of care)

NO INTERVENTION

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.

Interventions

Ready to use supplementary food (RUSF) 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.

Also known as: RUSF

Ready to use supplementary food (RUSF)

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Any other reason why the consenting investigator thinks it is not appropriate for them to take part.

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (2)

Kemri Wellcome Trust Research Programme

Kilifi, Coast Province, 80108, Kenya

Location

Kilifi District Hospital- OPD

Kilifi, Coast, 80108, Kenya

Location

MeSH Terms

Conditions

Malnutrition; Infections

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Limitations and Caveats

The trial was forced to stop early, 65 recruited. Analysis was inadequately powered to detect the changes in WHZ score and MUAC, the analysis of which had been originally planned for a sample size of 400.

Results Point of Contact

• Title: Dr James Berkley
• Organization: KEMRI/Wellcome Trust Research Programme

jberkley@kilifi.kemri-wellcome.org

+254 41 522535

Study Officials

• James A Berkley

  KEMRI-Wellcome Trust Collaborative Research Program

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Model Details: Open label randomised trial of nutrition products

Study Record Dates

• First Submitted: April 29, 2009
• First Posted: April 30, 2009
• Study Start: May 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: November 1, 2009
• Last Updated: August 14, 2017
• Results First Posted: July 19, 2013

Record last verified: 2017-06

Locations

KE (2)