NCT01300000

Brief Summary

The primary objective of the study is to compare the growth of infants fed standard infant formula with infants fed a reduced calorie and protein formula.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
649

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

March 1, 2010

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 21, 2011

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2017

Enrollment Period

4.5 years

First QC Date

February 17, 2011

Last Update Submit

March 27, 2017

Conditions

Infant Newborn

Outcome Measures

Primary Outcomes (1)

  • Weight gain

    1- 365 days

Secondary Outcomes (2)

  • Gastrointestinal tolerance

    1-365 days

  • Infant Anthropometrics

    1 - 365 days; 24 months

Other Outcomes (2)

  • Vascular

    at 24 months

  • Maternal Anthropometrics

    at 24 months

Study Arms (3)

Human Milk

ACTIVE COMPARATOR

ad lib

Other: Human Milk

Milk based standard infant formula

ACTIVE COMPARATOR

ad lib

Other: Milk based standard infant formula

Milk based investigational infant formula

EXPERIMENTAL

ad lib

Other: Investigational infant formula

Interventions

Human MilkOTHER

ad lib

Human Milk
Investigational infant formulaOTHER

ad lib

Milk based investigational infant formula
Milk based standard infant formulaOTHER

ad lib

Milk based standard infant formula

Eligibility Criteria

Age1 Minute - 24 Hours
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • good health
  • singleton birth with gestational age 37-42 weeks
  • infant's birth weight \>or = to 2500 grams
  • exclusive breastfeeding or exclusively formula feeding
  • within a defined geographical boundary
  • mother has no problems communicating in English

You may not qualify if:

  • adverse maternal, fetal or infant medical history
  • congenital disease or malformation affecting growth or development
  • illness or social problems in mother or infant
  • temporary residents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MRC Childhood Nutrition Research Center, Institute of Child Health

London, United Kingdom

Location

Related Publications (1)

  • Gonzalez-Garay AG, Serralde-Zuniga AE, Medina Vera I, Velasco Hidalgo L, Alonso Ocana MV. Higher versus lower protein intake in formula-fed term infants. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD013758. doi: 10.1002/14651858.CD013758.pub2.

    PMID: 37929831DERIVED

MeSH Terms

Interventions

Milk, Human

Intervention Hierarchy (Ancestors)

MilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Officials

  • Barbara Marriage, PhD

    Abbott Nutrition

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2011

First Posted

February 21, 2011

Study Start

March 1, 2010

Primary Completion

September 1, 2014

Study Completion

August 1, 2016

Last Updated

March 29, 2017

Record last verified: 2017-03

Locations

GB(1)