|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
26 October 2021 |
|
Main ID: |
NCT02594683 |
|
Date of registration:
|
29/10/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
A Follow-up Study to Investigate the Effects of a New Infant Formula on Growth and Body Composition
VenusFU |
|
Scientific title:
|
A Follow-up Study of a Randomised, Controlled, Study to Investigate the Effects of a New Infant Formula Given in the First 12 Months of Life on Growth and Body Composition up to 5 Years of Age |
|
Date of first enrolment:
|
August 2015 |
|
Target sample size:
|
359 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02594683 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Singapore
| | | | | | | |
|
Contacts
|
|
Name:
|
Jian Yi Soh, MBBS |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
National University Hospital, Singapore |
|
|
Name:
|
Oon Hoe Teoh, MBBS |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
KK Women's and Children's Hospital |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Participation in the intervention period of VENUS study until 12 months of age or
participation in the VENUS study as breast-fed reference group
- Written informed consent from parent(s) or legally acceptable representatives
Exclusion Criteria:
- Investigator's uncertainty about the willingness or ability of the child and parents
to comply with the protocol requirements
Age minimum:
3 Years
Age maximum:
5 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Healthy
|
|
Primary Outcome(s)
|
|
Body Mass Index (BMI)
[Time Frame: up to 5 years of age]
|
|
Secondary Outcome(s)
|
|
Z-scores of Height-for-age
[Time Frame: up to 5 years of age]
|
|
Z-score of Head circumference-for-age
[Time Frame: up to 5 years of age]
|
|
Z-score of Skinfold-for-age (subscapular, triceps)
[Time Frame: up to 5 years of age]
|
|
Sum of skin fold thicknesses (triceps, biceps, suprailiac, subscapular)
[Time Frame: up to 5 years of age]
|
|
Z-score of Mid-upper-arm-circumference-for-age
[Time Frame: up to 5 years of age]
|
|
Z-scores of BMI-for-age
[Time Frame: up to 5 years of age]
|
|
Z-scores of Weight-for-age
[Time Frame: up to 5 years of age]
|
|
Z-scores of Weight-for-height
[Time Frame: up to 5 years of age]
|
|
Secondary ID(s)
|
|
EBB15GL04185
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|