Effectiveness of Supplementary Feeding During Infection Among Moderately Malnourished Children

Malnutrition Clinical Trial

— MODMAL  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00890695
• Other study ID #: SSC 1415
• Status: Terminated
• Phase: N/A
• First received: April 29, 2009
• Last updated: June 17, 2013
• Start date: May 2009
• Est. completion date: November 2009

Study information

• Verified date: June 2013
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kenya: Ethical Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 64
• Est. completion date: November 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 5 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Malnutrition

Intervention

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.

Locations

Country	Name	City	State
Kenya	Kemri Wellcome Trust Research Programme	Kilifi	Coast Province
Kenya	Kilifi District Hospital- OPD	Kilifi	Coast

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	WHZ Score at 3 Months		between enrolment and 3 months	No
Secondary	MUAC for Age Z Score at 3 Months		between enrolment and 4 weeks and at 3 months	No
Secondary	Development of Severe Malnutrition (WHZ Score <-3 and/or Kwashiorkor)		at 4 weeks and 3 months	No
Secondary	Anemia (Hb <9.3g/dl)		at 4 weeks	No
Secondary	Hospital Admission or Death		from enrolment to 3 months	No