Effect of Formula on Growth of Infants From Overweight or... | NCT00820833

Studies
Effect of Formula on Growth of Infants From Overweight or Obese Mothers

NCT00820833

Sponsor

Société des Produits Nestlé (SPN)

Status

Completed

Last Update Posted

Mar 26, 2015Estimated

Enrollment

230Actual

Phase

Not Applicable

Conditions

Infant Nutrition

Interventions

standard infant formula
Test formula

Countries

Chile

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

Dec 2014

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

Oct 2007

Primary Completion Date

Jun 2010Actual

Completion Date

Dec 2014Actual

First Submitted Date

Jan 8, 2009

First Submission Date that Met QC Criteria

Jan 8, 2009

First Posted Date

Jan 12, 2009Estimated

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

Mar 25, 2015

Last Update Posted Date

Mar 26, 2015Estimated

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

The purpose of this study is to determine whether infants, from overweight or obese mothers, fed a formula with proteins and calories different than a standard infant formula have a different growth

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

230Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Placebo Comparator	Standard infant formula	Other: standard infant formula
2	Experimental	Test formula	Other: Test formula
3	No Intervention	Breastfeeding reference group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
standard infant formula	Other	standard infant formula given from 3 to 12 months of age, as per standard requirement	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mean weight gain		3 months

Secondary Outcomes

Measure	Description	Time Frame
blood test assessments; body composition, bone density		9 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy newborn infant
birth weight between 2500g and 4800g
singleton birth
mother's BMI before pregnancy was between 26 and 25
for the breastfeeding group: mother has elected to exclusively breastfeed her baby from birth to at least 6 months of age
for the formula groups: mother has elected to exclusively formula feed her baby from 3 to 6 months of age
having obtained signed informed consent of legal representative

Exclusion Criteria:

body weight smaller than 5th percentile for that gestational age
newborn whose mother has diabetes
newborn whose mother has a drug dependence during pregnancy
newborn currently participating in another trial

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

12 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jaime Inostroza, PhD	Universidad de La Frontera	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Departamento de Medicina Interna, University de la Frontera		Temuco			Chile

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24637965	Derived	Inostroza J, Haschke F, Steenhout P, Grathwohl D, Nelson SE, Ziegler EE. Low-protein formula slows weight gain in infants of overweight mothers. J Pediatr Gastroenterol Nutr. 2014 Jul;59(1):70-7. doi: 10.1097/MPG.0000000000000349.

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases