Plain English Summary
Background and study aims
Moderate acute child malnutrition (MAM) is a major global health problem, affecting about 36 million children worldwide. Children with moderate acute malnutrition are thin, and compared to a reference, do not weigh as much for their particular height as they should. As a result they have an increased risk of illness, reduced physical and mental development, and death. In emergencies or during recurrent food crisis children with MAM have traditionally been treated with fortified blended foods, such as Corn Soy Blends (CSB). It is now well recognized that CSB is inadequate for small children and products therefore need to be improved. Recently, improved CSBs (iCSBs) and lipid-based nutrient supplements (LNS) have been proposed as an alternative and are being tested. However, there is no consensus on the most suitable product and there is a need to develop and test new products. Twelve investigational food supplements will be developed, including six iCSBs and six LNS combining different soy qualities (dehulled soy, soy isolate) and different amounts of dried skimmed milk. This study aims to assess the effectiveness of a 3-month supplementation with these new products for the management in 6-23 months old children with MAM. Effectiveness will be assessed by determining their effects on body composition (i.e., how much fat and fat-free mass a childs body consists of), linear growth, physical activity, child development as well as other biological indicators of nutritional status, growth and infection. It will also be investigated whether children like the supplements.
Who can participate?
Children suffering from MAM
What does the study involve?
Each child is randomly allocated to receive one of the 12 supplements for a period of 3 months. During these 3 months the child should come to the health centre twice a month. After the 3 months supplementation period the child is asked to come to the centre once a month for a further 3 months period for follow-up. Mothers benefit from regular health, hygiene and nutrition education and children will undergo the following examinations:
1. Medical examination and treatment for any condition if necessary
2. Body measurements such as weight, height, mid-upper arm circumference, the length between knee and heel, and the thickness of the skin on the triceps and shoulder blade
3. Blood sampling. The blood is used for testing other indicators of nutritional status, growth and infections
4. Assessment of the child's motor and language development
5. Assessment of physical activity using an accelerometer, a small electronic device attached to a belt worn around the hips of the children
6. Measurement of the thymus size, an organ which plays a role in defence against infections, using an ultrasound scanner
7. Body composition assessment
In addition, participants are asked questions about the type of food the child and the rest of the household usually eat, and if the children likes the supplementary foods. Of these examinations only the medical examinations and body measurements are done at every visit. Assessment of child development, physical activity and blood sampling are only done three times: at the start and after 3 and 6 months. Body composition is assessed only twice, at admission and after 3 months.
What are the possible benefits and risks of participating?
The supplements may improve management of MAM
Where is the study run from?
Province du Passoré (Burkina Faso)
When is the study starting and how long is it expected to run for?
August 2013 to September 2014
Who is funding the study?
Danish International Development Assistance (Denmark)
Who is the main contact?
Prof. Henrik Friis
hfr@life.ku.dk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Henrik Friis
ORCID ID
Contact details
Department of Nutrition
Exercise and Sports
Rolighedsvej 30
Frederiksberg
1958
Denmark
-
hfr@life.ku.dk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effectiveness of improved diets for children with moderate acute malnutrition: a randomized controlled trial in Province du Passoré, Burkina Faso
Acronym
TreatFOOD
Study hypothesis
The research question is, which of twelve experimental food supplements, is most cost-effective in increasing lean body mass, and to improve functional outcomes, among 6-23 month-old children with moderate acute malnutrition.
Ethics approval
1. Ethics Board in Burkina Faso, 01/08/2012, ref: 2012-8-059
2. Consultative approval from the Danish Ethics Board, 25/09/2012, Case No: 1208204 and Document No. 1046935
Study design
Randomised nutrition intervention trial with a 2-by-2-by-3 factorial design
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Children with moderate acute malnutrition
Intervention
Children will receive one of 12 newly developed food products at a quantity of 500kcal per day for 12 weeks. No placebo or non-intervention group exists.
The 12 products include 6 improved CSBs and 6 lipid based nutrient supplements.The 12 products to be tested will all have the same micronutrient content, based on the WHO technical note on Supplementary foods for the management of moderate acute malnutrition in infants and children 659 months of age (WHO, 2012), but will have different amounts of milk powder and either dehulled soy or soy isolate, a higher quality soy. That is the CSBs and LNS products will based either on dehulled soy or on soy isolate and containing either 0%, 20% or 50% of proteins provided by dry skimmed milk.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Absolute lean mass increment from baseline to 3 months measured using the deuterium dilution method
Secondary outcome measures
1. Increase of WHZ to >-2 and linear growth, i.e. length and kneeheel length. Weight and knee-heel length measured at every bimonthly visit during the supplementation period and every monthly visit during the follow-up period. Height measured once a month.
2. Increase in mid upper arm circumference > 125 mm
3. Physical activity measured using an accelerometer, at 0, 3 and 6 months
4. Motor and language milestones development, measured using a adapted version of the Malawi Development Assessment Tool (MDAT) at 0, 3 and 6 months
5. Morbidity assessed during a clinical examination by a trained nurse and biological indicators measured in venous blood at every bimonthly visit during the supplementation period and every monthly visit during the follow-up period
6. Level of biological indicators of nutritional status, growth and immune function (haemoglobin, serum acute phase proteins, serum ferritin, essential fatty acids, insulin-like growth factor-1) measured in a venous blood sample taken from the childs arm at 0, 3 and 6 months
7. Thymus size measured using an ultrasound scanner at 0, 3 and 6 months
8. Acceptability of and adherence of products assessed using an acceptability questionnaire
Overall trial start date
19/08/2013
Overall trial end date
01/09/2014
Reason abandoned
Eligibility
Participant inclusion criteria
1. Weight-for-height z-score (WHZ) ≥ -3 and < -2 (based on the WHO growth standard) or Mid Upper Arm Circumference (MUAC) ≥115mm and < 125 mm
2. 6 to 23 months of age
3. Resident in the catchment area at the time of inclusion
4. Whose parents/guardians have signed (or thumb-printed whenever illiterate) the informed consent
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
1608
Participant exclusion criteria
1. Children with severe acute malnutrition defined as a WHZ < -3, and/or a MUAC <115 mm, and/or bilateral pitting oedema.
2. Children with medical complications requiring hospitalization
3. Children whose household plans to leave the catchment area in the next 6 months
4. Children with a hemoglobin concentration <4g/dl or with evidence of a decompensate anemia (e.g. dyspnea, tachycardia etc)
5. Children who have been treated for SAM or who have been hospitalized in the last 2 months
6. Children with known allergy to milk, peanut, corn soya blend (CSB) and/or ready to use therapeutic food (RUTF)
7. Children with a severe disability limiting the possibility of investigations
8. Children enrolled in any other nutritional program or part of any other study conducted in the area
Recruitment start date
19/08/2013
Recruitment end date
01/09/2014
Locations
Countries of recruitment
Burkina Faso
Trial participating centre
University of Copenhagen
Frederiksberg
1958
Denmark
Sponsor information
Organisation
University of Copenhagen (Denmark)
Sponsor details
Department of Nutrition
Exercise and Sports
Rolighedsvej 30
Frederiksberg
1958
Denmark
-
hfr@life.ku.dk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Doctors Without Borders (Médecins sans Frontieres) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Danish International Development Assistance (09-097 LIFE) (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2016 observational study results in: http://www.ncbi.nlm.nih.gov/pubmed/26739038
2017 cross-sectional study results in: http://www.ncbi.nlm.nih.gov/pubmed/28705254
2017 main study results in: http://www.ncbi.nlm.nih.gov/pubmed/28892496