Treating Moderate Malnutrition in 6-24 Months Old Children (LUCOMA)

This study has been completed.
Sponsor:
Collaborators:
Institut de Recherche en Sciences de la Sante, Burkina Faso
Ministry of Health, Burkina Faso
University Ghent
Information provided by (Responsible Party):
Institute of Tropical Medicine, Belgium
ClinicalTrials.gov Identifier:
NCT01115647
First received: April 29, 2010
Last updated: November 21, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Moderate Acute Malnutrition
Dietary Supplement: Ready-to-Use Therapeutic Food (RUTF)
Dietary Supplement: CBS++
Behavioral: CCC

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

Resource links provided by NLM:


Further study details as provided by Institute of Tropical Medicine, Belgium:

Primary Outcome Measures:
  • Recovery rate [ Time Frame: One month (average) ] [ Designated as safety issue: No ]
    Weight-for-Height Z-score≥-1 SD

  • Morbidity rate [ Time Frame: One month (average) ] [ Designated as safety issue: No ]
    ARI, diarrhoea, anaemia and malaria incidence. Morbidity will be assessed every week by a locally pre-tested standardized questionnaire

  • Cost-effectiveness [ Time Frame: Twelve months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Time to recovery [ Time Frame: One month (average) ] [ Designated as safety issue: No ]
  • Relapse rate [ Time Frame: Up to three months (average) ] [ Designated as safety issue: No ]
    Patients representing inclusion criteria within 3 months following discharge

  • Failure rate [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Patients not gaining weight after 2 weeks or with a Weight-for-Height Z-score<-1 SD after 8 weeks

  • Default rate [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Patient absent or refusing food during 2 consecutive weeks

  • Satisfaction of parents and acceptability [ Time Frame: Three months (average) ] [ Designated as safety issue: No ]
    Survey to be conducted with households

  • Diet replacement & Intra-household dispatching of the food supplements [ Time Frame: Three months (average) ] [ Designated as safety issue: No ]
    Assessment with households

  • Retinol & soluble serum transferrin receptors (Iron markers) [ Time Frame: Three months (average) ] [ Designated as safety issue: No ]
    Retinol & soluble serum transferrin receptors (Iron markers)


Enrollment: 2088
Study Start Date: July 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ready-to-Use Therapeutic Foood (RUSF)

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)
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.
Active Comparator: CSB++

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++
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.
Active Comparator: Children Centered Counseling (CCC)

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
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.

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

Ages Eligible for Study:   6 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01115647

Locations
Burkina Faso
18 Health Centres in Houndé District
Houndé, Burkina Faso
Sponsors and Collaborators
Institute of Tropical Medicine, Belgium
Institut de Recherche en Sciences de la Sante, Burkina Faso
Ministry of Health, Burkina Faso
University Ghent
Investigators
Principal Investigator: Laetitia Ouedraogo Nikiema, MD, MSc IRSS, Burkina Faso
Study Director: Dominique Roberfroid, MD MSc MPhil ITM
Study Chair: Patrick Kolsteren, MD, PhD ITM, Antwerpen
  More Information

No publications provided

Responsible Party: Institute of Tropical Medicine, Belgium
ClinicalTrials.gov Identifier: NCT01115647     History of Changes
Other Study ID Numbers: ITMH0110
Study First Received: April 29, 2010
Last Updated: November 21, 2011
Health Authority: Burkina Faso: Ministry of Health

Keywords provided by Institute of Tropical Medicine, Belgium:
Malnutrition
Nutritional intervention
Behavioural intervention
Burkina Faso
Cluster randomize trial

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on July 23, 2014