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

This study has been terminated.
(New provision of supplementary feeds for moderately malnourished children in the study area.)
Sponsor:
Information provided by (Responsible Party):
Jay Berkley, University of Oxford
ClinicalTrials.gov Identifier:
NCT00890695
First received: April 29, 2009
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Malnutrition
Infection
Dietary Supplement: Ready to Use Supplementary Food (RUSF)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of an Outpatient Strategy of Ready to Use Supplementary Food (RUSF) Among Moderately Malnourished Children With Acute Infection

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Weight for Height z Score at 4 Weeks [ Time Frame: between enrolment and 4 weeks ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • WHZ Score at 3 Months [ Time Frame: between enrolment and 3 months ] [ Designated as safety issue: No ]
  • MUAC for Age Z Score at 3 Months [ Time Frame: between enrolment and 4 weeks and at 3 months ] [ Designated as safety issue: No ]
  • Development of Severe Malnutrition (WHZ Score <-3 and/or Kwashiorkor) [ Time Frame: at 4 weeks and 3 months ] [ Designated as safety issue: No ]
  • Anemia (Hb <9.3g/dl) [ Time Frame: at 4 weeks ] [ Designated as safety issue: No ]
  • Hospital Admission or Death [ Time Frame: from enrolment to 3 months ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: May 2009
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: RUSF
RUSF 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. It provides 507 kcal per 100g, 6% protein/energy ratio and 55% fat/energy ratio. Essential fatty acids contained are N-6 (linoleic acid) 6 kcal % and N-3 (o-linoleic) 0.3 kcal %. Vitamin and mineral premix (3%) provides the currently recommended nutrient intake for moderately malnourished children of minerals (K, Na, Ca, P, Mg, Fe, Zn, Cu, Se, I, Mn, Cr, Mo, F), Vitamins (thiamine, riboflavin, pyridoxine, niacin, Vit B12, folic acid, Vit C, Biotin, Pantothenic acid, Vitamins A,D,E and K). 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 Name: RUSF
No Intervention: Normal diet
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.

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.

  Eligibility

Ages Eligible for Study:   6 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890695

Locations
Kenya
Kemri Wellcome Trust Research Programme
Kilifi, Coast Province, Kenya, 80108
Kilifi District Hospital- OPD
Kilifi, Coast, Kenya, 80108
Sponsors and Collaborators
University of Oxford
Investigators
Principal Investigator: James A Berkley KEMRI-Wellcome Trust Collaborative Research Program
  More Information

No publications provided

Responsible Party: Jay Berkley, PI, University of Oxford
ClinicalTrials.gov Identifier: NCT00890695     History of Changes
Other Study ID Numbers: SSC 1415
Study First Received: April 29, 2009
Results First Received: January 15, 2013
Last Updated: June 17, 2013
Health Authority: Kenya: Ethical Review Committee

Keywords provided by University of Oxford:
supplementary feeding
moderate malnutrition
acute infection
developing country
children

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on July 22, 2014