Condition category
Nutritional, Metabolic, Endocrine
Date applied
29/07/2013
Date assigned
02/08/2013
Last edited
15/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 trial 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 child’s 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 will be enrolled in the study.

What does the study involve?
Each child will be randomly assigned 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 will be asked to come to the centre once a month for a further 3 months period for follow-up.
Mothers will 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 will be 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 will be 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 will be done at every visit. Assessment of child development, physical activity and blood sampling will only be done three times: at admission, after 3 months and 6 months. Body composition will be 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

http://www.treatfood.org

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 below 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 6–59 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 will be measured at every bimonthly visit during the supplementation period and every monthly visit during the follow-up period. Height will be 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) will be measured in a venous blood sample taken from the child’s arm at
0, 3 and 6 months
7. Thymus size will be measured using an ultrasound scanner at 0, 3 and 6 months
8. Acceptability of and adherence of products will be 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. Six 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

A total of 1608 participants will be recruited

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

Department of Nutrition, Exercise and Sports
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

http://www.ku.dk

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 results in: http://www.ncbi.nlm.nih.gov/pubmed/26739038

Publication citations

Additional files

Editorial Notes

15/06/2016: Publication reference added.