Moderate wasting in children 6-24 months of age Nutritional, Metabolic, Endocrine
Conditions
Interventions
Current interventions as of 26/08/2025:
Phase 1:
Children are randomised to one of three treatment arms: ready-to-use supplementary food (RUSF), locally available food (LAF) or microbiome-directed s
Sponsors
World Health Organisation
Eligibility
Sex/Gender
All
Age
6 Months to 24 Months
Inclusion criteria
Inclusion criteria: 1. Age 6-24 months 2. Moderately wasted i.e. WLZ =-2 and > -3 or MUAC 115 mm 3. Presenting with any of the following acute illnesses at a facility out-patient clinic or discharged from hospital after 3 days but 3 days duration. Milder illnesses, for example, skin or common cold/ cough will not be considered as significant acute illness as having these mild illnesses are less likely to cause children to enter a downward spiral of increased risk of morbidity/mortality] 3.4. malaria, defined as reported or measured (=38?C) fever and positive rapid diagnostic test, or 4. Consent for study participation from parent or legal guardian
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 28/03/2024: 1. Severe acute malnutrition (WLZ <-3 or MUAC <115 mm or oedema of both feet) 2. General danger signs (lethargic/unconscious, convulsions, unable to drink, vomits everything) 3. Severe illness (severe pneumonia or very severe disease, severe dehydration, neck stiffness) 4. Persistent diarrhoea (=14 days) 5. Chronic infections/illness or disability, e.g. TB, HIV, congenital defects, cerebral palsy 6. Require hospital admission 7. Well child attended clinic only for routine growth monitoring or immunization 8. Child receiving food supplements for moderate wasting 9. Treated for moderate wasting in the previous 3 months 10. Previously enrolled in the study 11. Child with any known history of food allergy or food intolerance 12. Another child in the same household already recruited into the study 13. Child lives outside the study area routinely or will be outside of the study area for more than two weeks in the upcoming 3 months. _____ Previous exclusion criteria: 1. Severe acute malnutrition (WLZ <-3 or MUAC <115 mm or oedema of both feet) 2. General danger signs (lethargic/unconscious, convulsions, unable to drink, vomits everything) 3. Severe illness (severe pneumonia or very severe disease, severe dehydration, neck stiffness) 4. Persistent diarrhoea (=14 days) 5. Chronic infections/illness or disability, e.g. TB, HIV, congenital defects, cerebral palsy 6. Require hospital admission 7. Well child attended clinic only for routine growth monitoring or immunization 8. Child receiving food supplements for moderate wasting 9. Treated for moderate wasting in the previous 3 months 10. Previously enrolled in the study 11. Child with any known history of food allergy or food intolerance 12. Another child in the same household already recruited into the study 13. Child lives outside the study area
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1: Anthropometric recovery at week 12 (defined as recovery from moderate wasting on weight-for-length z score [WLZ] or mid upper arm circumference [MUAC]) Phase 2: Anthropometric recovery at week 24 (defined as recovery from moderate wasting on weight-for-length z score or mid upper arm circumference) Recovery is defined as WLZ >-2.0 or MUAC =125 mm (depending on whether the child was ascertained to have moderate wasting at enrolment based on a WLZ -2.0 or MUAC =125 mm) that indicated moderate wasting at enrolment. If the child was moderately wasted on both parameters, improvement on any one as defined above is accepted as recovery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 28/03/2024: 1. Time to recovery between the three groups within the first 12 weeks 2. Mean change in i) Mid-upper arm circumference (MUAC, in mm), ii) Weight-for-length z-score (WLZ), iii) Weight-for-age z-score (WAZ), iv) Length-for-age z-score (LAZ): - between MDSF, LAF and RUSF from i) enrolment to 12 weeks and ii) enrolment to 24 weeks - between food voucher and standard care post-recovery support groups from week 12 to week 24 3. Mean change in tricep skinfold thickness measurements: - between MDSF, LAF and RUSF from i) enrolment to 12 weeks and ii) enrolment to 24 weeks - between food voucher and standard care post-recovery support groups from week 12 to week 24 4. Deterioration to SAM or death: - between MDSF, LAF and RUSF from i) enrolment to 12 weeks and ii) enrolment to 24 weeks - between food voucher and standard care post-recovery support groups from week 12 to week 24 5. All-cause mortality: - between MDSF, LAF and RUSF from i) enrolment to 12 weeks and ii) enrolment to 24 weeks - between food voucher and standard care post-recovery support groups from week 12 to week 24 6. Any hospitalisation (>24h): - between MDSF, LAF and RUSF from i) enrolment to 12 weeks and ii) enrolment to 24 weeks - between food voucher and standard care post-recovery support groups from week 12 to week 24 7. Deterioration to SAM: - between MDSF, LAF and RUSF from i) enrolment to 12 weeks and ii) enrolment to 24 weeks - between food voucher and standard care post-recovery support groups from week 12 to week 24 Additional exploratory outcomes We will also do an exploratory analyses of MDSF as compared to. LAF for all primary and secondary outcomes. _____ Previous secondary outcome measures: 1. Time to anthropometric recovery within the first 12 weeks (time-to-event): this will be defined as the number of days to anthropometric recovery within the first 12 weeks. The day of anthropometric recovery will be the visit day of recovery 2. | — |
Countries
Bangladesh, India, Mali, Nigeria, Pakistan, Tanzania
Outcome results
None listed