A Follow-up Study to Investigate the Effects of a New Inf... | NCT02594683

Studies
A Follow-up Study to Investigate the Effects of a New Infant Formula on Growth and Body Composition

NCT02594683

Sponsor

Danone Asia Pacific Holdings Pte, Ltd.

Status

Completed

Last Update Posted

Oct 18, 2021Actual

Enrollment

359Actual

Phase

Not provided

Conditions

Healthy

Interventions

Not provided

Countries

Singapore

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015Actual

Primary Completion Date

Sep 12, 2019Actual

Completion Date

Dec 2020Actual

First Submitted Date

Oct 29, 2015

First Submission Date that Met QC Criteria

Nov 2, 2015

First Posted Date

Nov 3, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2021

Last Update Posted Date

Oct 18, 2021Actual

Name	Class
National University Hospital, Singapore	OTHER
KK Women's and Children's Hospital	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

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. Participants from Venus study will be invited to participate in this follow-up study.

Hypothesis: Significant difference in body mass index (BMI) development for subjects who had received infant formula and follow on formula with scGOS/lcFOS/Nuturis® compared to the control product scGOS/lcFOS and standard formula. No significant difference in growth of subjects who had received infant formula and follow on formula with scGOS/lcFOS/Nuturis® compared to the breast-feeding reference group.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

359Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Body Mass Index (BMI)		up to 5 years of age

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

5 Years

Standard Ages

Child

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Oon Hoe Teoh, MBBS	KK Women's and Children's Hospital	Principal Investigator
Jian Yi Soh, MBBS	National University Hospital, Singapore	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National University Hospital, Singapore		Singapore		119074	Singapore
KK Women's and Children's Hospital

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided