An interventional study of Ready-to-Use Therapeutic Food (RUTF) and CBS++ in Moderate Acute Malnutrition, sponsored by Institute of Tropical Medicine, Belgium. Completed at 1 site in Burkina Faso. Open to participants aged 6 Months to 24 Months. Per ClinicalTrials.gov, last updated 2011-11-22.
Sponsored by Institute of Tropical Medicine, Belgium · Not applicable, Interventional, and Treatment
Child malnutrition is intimately associated to poverty and may be due to sub-optimal feeding behaviours, food insecurity at household level, or a combination of both. Acute malnutrition is a major contributor to under-5 mortality and morbidity in developing countries. While clinical guidelines for severe acute malnutrition (SAM) have been available for a decade, research on the management of moderate acute malnutrition (MAM) has lagged behind. Nonetheless, MAM is much more incident than SAM, it increases mortality risk by itself and requires special nutritional treatment. This study is thus meant to address this major gap, by testing the relative feasibility, effectiveness and cost-effectiveness of three innovative strategies for treating children with MAM aged 6-24 months : a locally produced Ready-to-Use Therapeutic Food (RUTF), a corn/soy blended flour (CSB++)provided by the World Food Program, and a specific and context-appropriate child-centred counselling.
The evaluation will be carried out as a cluster-randomized trial in the Houndé district, Burkina Faso, where 18 rural health centres will be randomly allocated to RUSF or CSB or CCC for treating MAM.
Child malnutrition is intimately associated to poverty and may be due to sub-optimal feeding behaviours, food insecurity at household level, or a combination of both. Acute malnutrition is a major contributor to under-5 mortality and morbidity in low and middle income countries. Clinical guidelines for the management of severe acute malnutrition (SAM) have been available for a decade and have yielded excellent results. However, the corresponding research on the management of moderate acute malnutrition (MAM) has lagged behind, even if MAM is much more incident than SAM, increases mortality risk on its own and requires special nutritional treatment. Currently, the main management of MAM, in Burkina Faso as in most African countries, consists of giving nutritional advice to the caretakers, but mothers of MAM children are usually given the same general dietary advice as mothers of well-nourished children. A more efficient, child-centred approach must be developed, by adapting the counselling to the needs of the family, by developing a more child-centred approach, by providing operational recommendations for MAM children, and by providing an adequate follow-up post-treatment.
This study is thus meant to address this major gap, by testing the relative feasibility, effectiveness and cost-effectiveness of three innovative strategies for treating children with MAM: a locally produced Ready-to-Use Therapeutic Food (RUTF), an enhanced corn/soy blended flour (CSB++)provided by the World Food Program, and a specific and context-appropriate child-centred counselling.
The evaluation will be based on a cluster-randomized trial carried out in the Houndé district, Burkina Faso. Eighteen rural health centres and the population living in their catchment area will be randomly allocated to RUSF or CSB or CCC for treating MAM. Only children aged 6-24 months will be included as the risk of acute malnutrition is high and more amenable to interventions in this age range. Overall, 2088 children with MAM will participate. In each study arm, children will be home-visited once a week by assessors for anthropometry, 24-hours recall of dietary and breastfeeding intake, and morbidity signs. Feeding practices will be also assessed in each arm, and the changes between baseline and intervention periods evaluated. Compliance will be evaluated by interviewing family members.
1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.
This study's enrollment of 2,088 is above the median of 90 across 1,134 interventional studies indexed under Malnutrition.
Browse Malnutrition studies →Institute of Tropical Medicine, Belgium is the lead sponsor of 103 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Caretakers will receive weekly RUSF, 350g, and will be advised to feed it(50 g d-1 or 3 tablespoons/day) in one meal or on demand. These are pre-defined quantities. However, minimum quantities required for a timely (≤15 days) recovery from moderate malnutrition will be determined during the pilot phase. Besides supplementary food, parents will be provided with the usual nutrition counsels prevailing currently in the health services.Children will be home-visited once a week by assessors for anthropometry, 24-hours recall of dietary and breastfeeding intake, and morbidity signs. Feeding practices will be assessed, and the changes between baseline and intervention periods evaluated. Compliance will be evaluated by interviewing family members.
Dietary Supplement: Ready-to-Use Therapeutic Food (RUTF)
Caretakers will receive weekly CSB++ (450g) rations. Parents will be advised to feed the CSB++ (65g d-1 diluted in 370 g water) in one meal or on demand. These are pre-defined quantities. However, minimum quantities of CSB++ required for a timely (≤15 days) recovery from moderate malnutrition in the area will be determined during the pilot phase. Besides supplementary foods, parents will be provided with the usual nutrition counsels prevailing currently in the health services, i.e. to keep on breastfeeding, to increase diet diversity and to feed frequent snacks. Feeding practices will be also assessed, and the changes between baseline and intervention periods evaluated. Compliance will be evaluated by interviewing family members.
Dietary Supplement: CBS++
The counsellor will spend 1 hour daily (during the 3 first days and then weekly) within the household for identifying enhancing and blocking factors and adapt consequently the treatment strategies in agreement with the caretakers. As in the other study arms, children will be home-visited once a week by assessors for anthropometry, 24-hours recall of dietary and breastfeeding intake, and morbidity signs. Feeding practices will be also assessed in each arm, and the changes between baseline and intervention periods evaluated. Compliance will be evaluated by interviewing family members.There will be no dietary supplements intervention, outside normal practices in Burkina.
Behavioral: CCC
A Ready-to-Use Therapeutic Food (RUTF), locally produced in Burkina Faso. The RUSF will be nutritionally characterized by chemical analysis (macronutrients, amino acids, vitamins A, C, D, E, B12, thiamin, riboflavin, niacin, calcium, iron, zinc, copper, selenium) and will be analyzed for macronutrients and energy density. All analysis methods are either based on the Official Methods of Analysis of AOAC International or in-house validated analytical methods. The pilot production phase and Hazard Analysis of Critical Control Points (HACCP) risk inventory of the production process will be performed by a food technologist from the Department of Food safety and Food quality, Ghent University.
CSB is a low-cost combination of a cereal and a legume sometimes fortified with micronutrients. However, it presents shortcomings such as too many anti-nutrients, suboptimal micronutrient content, high bulk and viscosity. The World Food Program has recently proposed an enhanced CSB, named CSB++, which is prepared from heat treated maize and de-hulled soya beans, sugar, dried skim milk, refined soya bean oil, vitamins and minerals.
Child-Centred dietary Counselling (CCC). Although educational/behavioral interventions can be effective to improve child growth, there is little evidence of their effectiveness for MAM. Moreover, evidence from Africa is inexistent. Currently, the main management of MAM consists of giving nutritional advice to the caretakers, but mothers of MAM children are given the same general dietary advice as mothers of well-nourished children. A more efficient, child-centred approach is therefore proposed, by adapting the counselling to the needs of the family, developing a more child-centred approach, by providing operational recommendations for MAM children and providing an adequate follow-up post-treatment.
Recovery rate
Weight-for-Height Z-score≥-1 SD
Time frame: One month (average)
Morbidity rate
ARI, diarrhoea, anaemia and malaria incidence. Morbidity will be assessed every week by a locally pre-tested standardized questionnaire
Time frame: One month (average)
Cost-effectiveness
The net differential costs and key outcomes for each intervention will be used to calculate the incremental cost-effectiveness ratios, i.e. the incremental costs divided by the incremental benefits. Specific cost-utility analysis will be performed to disentangle costs of a routine program including the intervention elements from those incurred from the research activities of the project.
Time frame: Twelve months
Time to recovery
Time frame: One month (average)
Relapse rate
Patients representing inclusion criteria within 3 months following discharge
Time frame: Up to three months (average)
Failure rate
Patients not gaining weight after 2 weeks or with a Weight-for-Height Z-score\<-1 SD after 8 weeks
Time frame: 8 weeks
Default rate
Patient absent or refusing food during 2 consecutive weeks
Time frame: 2 weeks
Satisfaction of parents and acceptability
Survey to be conducted with households
Time frame: Three months (average)
Diet replacement & Intra-household dispatching of the food supplements
Assessment with households
Time frame: Three months (average)
Retinol & soluble serum transferrin receptors (Iron markers)
Retinol \& soluble serum transferrin receptors (Iron markers)
Time frame: Three months (average)
This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Institute of Tropical Medicine, Belgium