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Management of moderate malnutrition in children presented with acute illness

A three-arm, parallel group, open label, randomized trial of three supplements for the nutritional management of moderate wasting in children 6-24m of age with acute illness. - Nutri-MAM Study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/060203
Enrollment
1272
Registered
2023-11-23
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E440- Moderate protein-calorie malnutrition

Interventions

Intervention1: Home available foods(LAF): The caregiver will be provided with home available raw ingredients such as cereals and pulses, flour, nuts, sugar, oil, milk, fruit and eggs etc. to prepare e

Sponsors

Center for Public Health Kinetics
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age 6-24 months, and 2.Moderately wasted i.e. WLZ -3 or MUAC 115 mm, and 3.Presenting with any of the following acute illnesses at a facility out-patient clinic or discharged from hospital after a.diarrhea, defined as 3 or more loose or watery stools (with or without blood) in the previous 24 hours, and no dehydration on assessment. If the child has dehydration, the dehydration will be treated re-assessing for recruitment, or b.pneumonia, defined as presence before of fast breathing or chest indrawing, or c.Non-malarial fever, defined as reported or measured (>= 38á´¼C) fever of >3 days but duration d.malaria, defined as reported or measured (>= 38á´¼C) fever and positive rapid diagnostic test, or 4. Consent for study participation from parent or legal guardian

Exclusion criteria

Exclusion criteria: 1.Severe acute malnutrition (WLZ 2.General danger sign (lethargic/unconscious, convulsions, unable to drink, vomits everything) 3.Severe illness (severe pneumonia or very severe disease, severe dehydration, neck stiffness) 4.Persistent diarrhoea (>=14d) 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 lives outside the study area

Design outcomes

Primary

MeasureTime frame
- Anthropometric recovery from moderate wasting at any point up to 12 weeks after enrolment. - Sustenance of anthropometric recovery at 24 weeks Timepoint: 1. weekly visit from enrollemnt to 12 weeks for recovery. 2. once at 24 weeks post enrollment for sustenance.

Secondary

MeasureTime frame
-Median time to recovery -Mean change in Mid-upper arm circumference (MUAC in mm) and Weight-for-length z-score (WLZ) from enrolment to 12 weeks. -Proportion of children achieving a change in WLZ greater equal to 0.5 from baseline at any point up to 12 weeks after enrolment -Mean change in WAZ and LAZ scores, from enrolment to 12 weeks -Change in skinfold thickness measurements from enrolment to 12 weeks. - Deterioration to SAM or death up to 12 weeks -All-cause mortality, from enrolment to 24 weeks. - Any hospitalisation (greater than 24h) from enrolment to 24 weeksTimepoint: 1. Between enrollment and recovery by weekly visitation till 12 weeks. 2. End study visitation at 24 weeks.

Countries

India

Contacts

Public ContactSunil Sazawal

Center for Public Health Kinetics

ssazawal@jhu.edu91-11-41724901

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026