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Comparing compliance and efficacy of isocaloric oral supplementation using 1.5 Kcal/mL or 1 Kcal/mL sip feeds in mild to moderate malnutrition in children

Comparing compliance and efficacy of isocaloric oral supplementation using 1.5 Kcal/mL or 1 Kcal/mL sip feeds in mild to moderate malnutrition in children: an open label, parallel, randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN72956594
Enrollment
110
Registered
2011-05-09
Start date
2011-05-02
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Mild to moderate malnutrition Nutritional, Metabolic, Endocrine Malnutrition

Interventions

Ready to drink oral supplementation 600 kcal for 28 days. Study group will receive 2 bottles each 200 mL, 1.5 kcal/mL product. Controlled group will receive 3 bottles each 200 mL 1kcal/mL product. Th

Sponsors

University of Indonesia (Indonesia)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Boys and girls aged 3-5 years 2. Z-score for weight-for-height is -1 to -3 according to the World Health Organisation (WHO 2006) growth standards 3. Child is used to drinking milk 4. Stable health status (in the opinion of the Health Care Professional) 5. Written informed consent from parents/caretakers

Exclusion criteria

Exclusion criteria: 1. Taking medications which increase appetite (appetite stimulants), such as steroids, cyproheptadine 2. Conditions which need a special diet like major renal and hepatic dysfunction 3. Known cow?s milk allergy, galactosaemia, major gastrointestinal intolerance (e.g. severe vomiting, severe diarrhoea) 4. Children requiring a fiber-free diet 5. Children with oedema 6. Use of parenteral feeding and/or enteral tube-feeding 7. Investigator's uncertainty about the willingness or ability of the child/caretaker to comply with the protocol requirements 8. Participation in any other study involving investigational or marketed products concomitantly or within two weeks prior to entry into the study

Design outcomes

Primary

MeasureTime frame
1. Weight gain: measure body weight every week of intervention 2. Product consumption: measure the remainings in bottle(s) 3.Gastrointestinal complaints: questionnaire and bristol stool chart

Secondary

MeasureTime frame
Calorie intake from solid food before and after intervention: 24 recall diet before (day 1) and after intervention (day 29)

Countries

Indonesia

Outcome results

None listed

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