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Comparison of 10% milk ready-to-use food to 25% milk ready-to-use food in the treatment of severely malnourished, Malawian children

Randomised, double-blind controlled clinical effectiveness trial comparing 10% milk ready-to-use food with 25% milk ready-to-use food (RUTF) in the treatment of severe acute malnutrition in rural Malawian children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN54186063
Enrollment
1800
Registered
2009-06-04
Start date
2008-01-06
Completion date
Unknown
Last updated
2021-01-11

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

Conditions

Childhood severe acute malnutrition Nutritional, Metabolic, Endocrine Unspecified severe protein-energy malnutrition

Interventions

The randomised food product, 10% milk RUTF or 25% milk RUTF, sufficient for two weeks' feeding to the treated child will be given to the subject's caretaker with instructions on daily feeding methods

Sponsors

University of Malawi College of Medicine (Malawi)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Children aged 12 - 60 months, either sex 2. Suffering from severe acute malnutrition 3. Reside within 7 kilometres of and present to one of the 15 feeding sites during the recruitment period

Exclusion criteria

Exclusion criteria: 1. Not permanent residents in the vicinity of one of the feeding sites 2. Severe chronic illness, e.g., cerebral palsy 3. A history of peanut allergy or anaphylaxis resulting from any food 4. Receiving other supplementary food 5. Participating in another research study

Design outcomes

Primary

MeasureTime frame
Recovery, defined as weight-for-height z-score greater than -2 on two consecutive visits.

Secondary

MeasureTime frame
1. Rates of gain in weight, height and mid-upper arm circumference 2. Adverse outcomes such as death 3. Number of days of fever, cough and diarrhoea Measured at each return visit, i.e. every two weeks until the child reached the final outcome of recovery/death/another outcome.

Countries

Malawi

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026