Effectiveness of Supplementary Feeding During Infection Among Moderately Malnourished Children (MODMAL)
Dietary Supplement: Ready to Use Supplementary Food (RUSF)
|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|
- 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.
- 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 ]
|Study Start Date:||May 2009|
|Study Completion Date:||November 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00890695
|Kemri Wellcome Trust Research Programme|
|Kilifi, Coast Province, Kenya, 80108|
|Kilifi District Hospital- OPD|
|Kilifi, Coast, Kenya, 80108|
|Principal Investigator:||James A Berkley||KEMRI-Wellcome Trust Collaborative Research Program|