Treating Moderate Malnutrition in 6-24 Months Old Children

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.

Conditions

• Moderate Acute Malnutrition

Interventions

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.

DIETARY_SUPPLEMENT

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.

Sponsors & Collaborators

• Institut de Recherche en Sciences de la Sante, Burkina Faso

  collaborator OTHER_GOV

• Ministry of Health, Burkina Faso

  collaborator OTHER_GOV

• University Ghent

  collaborator OTHER

• Institute of Tropical Medicine, Belgium

  lead OTHER

Principal Investigators

• Laetitia Ouedraogo Nikiema, MD, MSc · IRSS, Burkina Faso

• Dominique Roberfroid, MD MSc MPhil · ITM

• Patrick Kolsteren, MD, PhD · ITM, Antwerpen

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

24 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-07-31

Primary Completion

2011-11-30

Completion

2011-11-30

Countries

• Burkina Faso

Study Locations