NCT00366873

Brief Summary

The purpose of this study is to measure calcium absorption in infants fed formula with and without prebiotics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

5 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

First Submitted

Initial submission to the registry

August 17, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2006

Completed
11 days until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

March 5, 2009

Status Verified

March 1, 2009

Enrollment Period

2.3 years

First QC Date

August 17, 2006

Last Update Submit

March 4, 2009

Conditions

Healthy

Keywords

InfantTerm

Outcome Measures

Primary Outcomes (1)

  • Calcium absorption

    14 days

Secondary Outcomes (1)

  • Vitamin D levels

    14 days

Study Arms (2)

1

ACTIVE COMPARATOR

cow-milk based infant formula

Procedure: Calcium absorption

2

EXPERIMENTAL

cow-milk based infant formula with prebiotics

Procedure: Calcium absorption

Interventions

Calcium absorptionPROCEDURE

formula with or without prebiotics

12

Eligibility Criteria

Age56 Days - 70 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy, term infants

You may not qualify if:

  • Breast fed infants
  • Use of vitamin/mineral supplements
  • Currently on medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Fomon Infant Nutrition Unit

Coralville, Iowa, 52241, United States

Location

Pediatric Clinical Trials Unit

Louisville, Kentucky, 40202, United States

Location

The Center for Human Nutrition

Omaha, Nebraska, 68105, United States

Location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

Children's Research and Nutrition Center

Houston, Texas, 77030, United States

Location

Study Officials

  • James Heubi, M.D.

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 17, 2006

First Posted

August 21, 2006

Study Start

September 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

March 5, 2009

Record last verified: 2009-03

Locations

US(5)