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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00890695
Recruitment Status : Terminated (New provision of supplementary feeds for moderately malnourished children)
First Posted : April 30, 2009
Results First Posted : July 19, 2013
Last Update Posted : August 14, 2017
Information provided by (Responsible Party):
James Berkley, University of Oxford

April 29, 2009
April 30, 2009
January 15, 2013
July 19, 2013
August 14, 2017
May 2009
October 2009   (Final data collection date for primary outcome measure)
Weight for Height z Score at 4 Weeks [ Time Frame: between enrolment and 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.

Change in WHZ-score [ Time Frame: between enrolment and 4 weeks ]
Complete list of historical versions of study NCT00890695 on Archive Site
  • WHZ Score at 3 Months [ Time Frame: between enrolment and 3 months ]
  • MUAC for Age Z Score at 3 Months [ Time Frame: between enrolment and 4 weeks and at 3 months ]
  • Development of Severe Malnutrition (WHZ Score <-3 and/or Kwashiorkor) [ Time Frame: at 4 weeks and 3 months ]
  • Anemia (Hb <9.3g/dl) [ Time Frame: at 4 weeks ]
  • Hospital Admission or Death [ Time Frame: from enrolment to 3 months ]
  • Change in WHZ score [ Time Frame: between enrolment and 3 months ]
  • Changes in MUAC [ Time Frame: between enrolment and 4 weeks and at 3 months ]
  • Development of Severe Malnutrition (WHZ Score <-3 and/or Kwashiorkor) [ Time Frame: at 4 weeks and 3 months ]
  • Anemia (Hb <10g/dl) [ Time Frame: at 4 weeks ]
  • Hospital Admission or Death [ Time Frame: during study period and in the subsequent year ]
  • Differences in levels of immune activation and inflammatory markers [ Time Frame: at 4 weeks ]
Not Provided
Not Provided
Effectiveness of Supplementary Feeding During Infection Among Moderately Malnourished Children
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.

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.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Open label randomised trial of nutrition products
Masking: None (Open Label)
Primary Purpose: Treatment
  • Malnutrition
  • Infection
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 Name: RUSF
  • 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.
    Intervention: Dietary Supplement: Ready to use supplementary food (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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2009
October 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
6 Months to 5 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
SSC 1415
Not Provided
Not Provided
James Berkley, University of Oxford
University of Oxford
Not Provided
Principal Investigator: James A Berkley KEMRI-Wellcome Trust Collaborative Research Program
University of Oxford
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP