NCT02594683

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
359

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2015

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 3, 2015

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

October 18, 2021

Status Verified

October 1, 2021

Enrollment Period

4.1 years

First QC Date

October 29, 2015

Last Update Submit

October 14, 2021

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Body Mass Index (BMI)

    up to 5 years of age

Secondary Outcomes (8)

  • Sum of skin fold thicknesses (triceps, biceps, suprailiac, subscapular)

    up to 5 years of age

  • Z-scores of Weight-for-age

    up to 5 years of age

  • Z-scores of Weight-for-height

    up to 5 years of age

  • Z-scores of Height-for-age

    up to 5 years of age

  • Z-scores of BMI-for-age

    up to 5 years of age

  • +3 more secondary outcomes

Study Arms (3)

Key Group of Interest

Exclusively formula fed subjects since 1 month of age

Other-Fed Group

Mixed feeding of formula and breast milk

Breastfeeding Group

Exclusively breastfeeding at least until 4 months of age

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Participation in the intervention period of VENUS study until 12 months of age or participation in the VENUS study as breast-fed reference group

You may qualify if:

  • 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

You may not qualify if:

  • Investigator's uncertainty about the willingness or ability of the child and parents to comply with the protocol requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National University Hospital, Singapore

Singapore, 119074, Singapore

Location

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stools, saliva and blood (optional)

Study Officials

  • Oon Hoe Teoh, MBBS

    KK Women's and Children's Hospital

    PRINCIPAL INVESTIGATOR

  • Jian Yi Soh, MBBS

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2015

First Posted

November 3, 2015

Study Start

August 1, 2015

Primary Completion

September 12, 2019

Study Completion

December 1, 2020

Last Updated

October 18, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

SG(2)