Children with moderate acute malnutrition Nutritional, Metabolic, Endocrine Malnutrition
Conditions
Interventions
Children will receive one of 12 newly developed food products at a quantity of 500 kcal per day for 12 weeks. No placebo or non-intervention group exists.
The 12 products include 6 improved CSBs and
Sponsors
University of Copenhagen (Denmark)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute lean mass increment from baseline to 3 months measured using the deuterium dilution method | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 child?s 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 | — |
Countries
Burkina Faso, Denmark
Outcome results
None listed