Effectiveness of Supplementary Feeding During Infection Among Moderately Malnourished Children (MODMAL)

Randomized Controlled Trial of an Outpatient Strategy of Ready to Use Supplementary Food (RUSF) Among Moderately Malnourished Children With Acute Infection

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.

Study Overview

• Status: Terminated
• Conditions: Malnutrition; Infection
• Intervention / Treatment: Dietary supplement: Ready to use supplementary food (RUSF)

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Coast
    • Kilifi, Coast, Kenya, 80108
      • Kilifi District Hospital- OPD
  • Coast Province
    • Kilifi, Coast Province, Kenya, 80108
      • KEMRI Wellcome Trust Research Programme

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 5 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Dietary supplement: 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.; Other Names: RUSF
NO_INTERVENTION: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Oxford
• Investigators: Principal Investigator: James A Berkley, KEMRI-Wellcome Trust Collaborative Research Program

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (ACTUAL): October 1, 2009
• Study Completion (ACTUAL): November 1, 2009

Study Registration Dates

• First Submitted: April 29, 2009
• First Submitted That Met QC Criteria: April 29, 2009
• First Posted (ESTIMATE): April 30, 2009

Study Record Updates

• Last Update Posted (ACTUAL): August 14, 2017
• Last Update Submitted That Met QC Criteria: June 30, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: children; developing country; acute infection; supplementary feeding; moderate malnutrition
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Nutrition Disorders; Infections; Communicable Diseases; Malnutrition
• Other Study ID Numbers: SSC 1415