Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
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
Acronym
Study hypothesis
Is compliance and efficafy of high calorie supplementation given orally better than standard one in mild to moderate malnurished children?
Ethics approval
Ethical Committee Faculty of Medicine of University of Indonesia approved on April 25th 2011 (224/PT02.FK/43/N/2011)
Study design
Open label parallel randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Mild to moderate malnutrition
Intervention
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.
The randomisation was done by a statistician not included in this study. He then sealed in the envelopes with consecutive number at front page. If a patient enters the study, we pick number accordingly then check the code inside. The code is A or B. The investigator knows what the codes A and B are for but the statistician doesn't. After completion of the study, the statistician will analyse the data and at the end, we all meet to hear the result from him and disclose the code to the statistician.
Intervention type
Supplement
Phase
Not Applicable
Drug names
Isocaloric oral supplementation
Primary outcome measures
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 outcome measures
Calorie intake from solid food before and after intervention: 24 recall diet before (day 1) and after intervention (day 29)
Overall trial start date
02/05/2011
Overall trial end date
30/06/2011
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
110
Participant 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 cows 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
Recruitment start date
02/05/2011
Recruitment end date
30/06/2011
Locations
Countries of recruitment
Indonesia
Trial participating centre
Departemen Ilmu Kesehatan Anak Fkui
Jakarta
10430
Indonesia
Funders
Funder type
Industry
Funder name
Nutricia (Indonesia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary