Clinical trial NCT01115647: Treating Moderate Malnutrition in 6-24 Months Old Children
Official title: Treating Moderate Malnutrition in 6-24 Months Old Children: Acceptability, Efficacy and Cost-effectiveness of a Local Soy-based RUTF vs. Enhanced Corn Soy Blend vs. Child-centered Counselling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Moderate Acute Malnutrition
Keywords: Malnutrition
Nutritional intervention
Behavioural intervention
Burkina Faso
Cluster randomize trial
Lead sponsor: Institute of Tropical Medicine, Belgium
Sponsor class: OTHER
Collaborators: name: Institut de Recherche en Sciences de la Sante, Burkina Faso
name: Ministry of Health, Burkina Faso
name: University Ghent
First posted: 2010-05-04
Enrollment: 2088
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* living in the catchment area of one of the 18 health centres participating in this cluster randomized trial
* 6-24 months of age
* -3≤ weight for height z score \<-2 without edema
* No major clinical complications
* Showing appetite

Exclusion Criteria:

* Weight-for-Height Z-score \<-3 and/or the presence of bilateral
* Presence of bilateral pitting oedema
* Not showing appetite

Primary outcomes:
measure: Recovery rate
timeFrame: One month (average)
measure: Morbidity rate
timeFrame: One month (average)
measure: Cost-effectiveness
timeFrame: Twelve months
Secondary outcomes:
measure: Time to recovery
timeFrame: One month (average)
measure: Relapse rate
timeFrame: Up to three months (average)
measure: Failure rate
timeFrame: 8 weeks
measure: Default rate
timeFrame: 2 weeks
measure: Satisfaction of parents and acceptability
timeFrame: Three months (average)
measure: Diet replacement & Intra-household dispatching of the food supplements
timeFrame: Three months (average)
measure: Retinol & soluble serum transferrin receptors (Iron markers)
timeFrame: Three months (average)
Other outcomes:
Locations:
city: Houndé
country: Burkina Faso
facility: 18 Health Centres in Houndé District
Study officials:
affiliation: IRSS, Burkina Faso
name: Laetitia Ouedraogo Nikiema, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: ITM
name: Dominique Roberfroid, MD MSc MPhil
role: STUDY_DIRECTOR
affiliation: ITM, Antwerpen
name: Patrick Kolsteren, MD, PhD
role: STUDY_CHAIR
References:
citation: Nikiema L, Huybregts L, Kolsteren P, Lanou H, Tiendrebeogo S, Bouckaert K, Kouanda S, Sondo B, Roberfroid D. Treating moderate acute malnutrition in first-line health services: an effectiveness cluster-randomized trial in Burkina Faso. Am J Clin Nutr. 2014 Jul;100(1):241-9. doi: 10.3945/ajcn.113.072538. Epub 2014 May 7.