Condition category
Nutritional, Metabolic, Endocrine
Date applied
28/04/2011
Date assigned
09/05/2011
Last edited
09/05/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Yoga Devaera

ORCID ID

Contact details

Departemen Ilmu Kesehatan Anak Fkui
Jl Salemba 6
Jakarta
10430
Indonesia

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 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

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

Sponsor information

Organisation

University of Indonesia (Indonesia)

Sponsor details

Deapartment of Child Health
Faculty of Medicine
c/o Dr Yoga Devaera
Jakarta
10430
Indonesia

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes