Treating Moderate Malnutrition in 6-24 Months Old Children

Moderate Acute Malnutrition Clinical Trial

— LUCOMA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01115647
• Other study ID #: ITMH0110
• Status: Completed
• Phase: N/A
• First received: April 29, 2010
• Last updated: November 21, 2011
• Start date: July 2010
• Est. completion date: November 2011

Study information

• Verified date: November 2011
• Source: Institute of Tropical Medicine, Belgium
• Contact: n/a
• Is FDA regulated: No
• Health authority: Burkina Faso: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2088
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 24 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malnutrition
• Moderate Acute Malnutrition

Intervention

Dietary Supplement:
• Ready-to-Use Therapeutic Food (RUTF)
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.
• CBS++
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.

Behavioral:
• CCC
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.

Locations

Country	Name	City	State
Burkina Faso	18 Health Centres in Houndé District	Houndé

Sponsors (4)

Lead Sponsor	Collaborator
Institute of Tropical Medicine, Belgium	Institut de Recherche en Sciences de la Sante, Burkina Faso, Ministry of Health, Burkina Faso, University Ghent

Country where clinical trial is conducted

Burkina Faso, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery rate	Weight-for-Height Z-score=-1 SD	One month (average)	No
Primary	Morbidity rate	ARI, diarrhoea, anaemia and malaria incidence. Morbidity will be assessed every week by a locally pre-tested standardized questionnaire	One month (average)	No
Primary	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.	Twelve months	No
Secondary	Time to recovery		One month (average)	No
Secondary	Relapse rate	Patients representing inclusion criteria within 3 months following discharge	Up to three months (average)	No
Secondary	Failure rate	Patients not gaining weight after 2 weeks or with a Weight-for-Height Z-score<-1 SD after 8 weeks	8 weeks	No
Secondary	Default rate	Patient absent or refusing food during 2 consecutive weeks	2 weeks	No
Secondary	Satisfaction of parents and acceptability	Survey to be conducted with households	Three months (average)	No
Secondary	Diet replacement & Intra-household dispatching of the food supplements	Assessment with households	Three months (average)	No
Secondary	Retinol & soluble serum transferrin receptors (Iron markers)	Retinol & soluble serum transferrin receptors (Iron markers)	Three months (average)	No