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
| ISRCTN | ISRCTN72956594 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72956594 |
| Secondary identifying numbers | N/A |
- Submission date
- 28/04/2011
- Registration date
- 09/05/2011
- Last edited
- 09/05/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Yoga Devaera
Scientific
Scientific
Departemen Ilmu Kesehatan Anak Fkui
Jl Salemba 6
Jakarta
10430
Indonesia
Study information
| Study design | Open label parallel randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | Is compliance and efficafy of high calorie supplementation given orally better than standard one in mild to moderate malnurished children? |
| Ethics approval(s) | Ethical Committee Faculty of Medicine of University of Indonesia approved on April 25th 2011 (224/PT02.FK/43/N/2011) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 02/05/2011 |
| Completion date | 30/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Years |
| Upper age limit | 5 Years |
| Sex | Both |
| Target number of participants | 110 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 02/05/2011 |
| Date of final enrolment | 30/06/2011 |
Locations
Countries of recruitment
- Indonesia
Study participating centre
Departemen Ilmu Kesehatan Anak Fkui
Jakarta
10430
Indonesia
10430
Indonesia
Sponsor information
University of Indonesia (Indonesia)
University/education
University/education
Deapartment of Child Health
Faculty of Medicine
c/o Dr Yoga Devaera
Jakarta
10430
Indonesia
"ROR" |
https://ror.org/0116zj450 |
|---|
Funders
Funder type
Industry
Nutricia (Indonesia)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
