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CompletedNCT01177917Updated Aug 9, 2010

Evaluation of Mineral Absorption in Infants Fed Infant Formula

An interventional study of Infant Formula in Mineral Absorption in the Urine, sponsored by Mead Johnson Nutrition. Completed at 5 sites in United States. Open to participants aged 56 Days to 70 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-08-09.

Sponsored by Mead Johnson Nutrition · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Ages
56 Days to 70 Days
Sex
All
01

Study summary

This clinical trial will help determine if prebiotics can increase mineral absorption in babies

02

Conditions studied

  • Mineral Absorption in the Urine
03

In context

Lead sponsor

Mead Johnson Nutrition is the lead sponsor of 56 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
56 Days to 70 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Singleton
  • Term infant
  • Birth weight of 2500 g or more
  • 56-70 days of age
  • Signed informed consent
  • Consuming a cow's milk-based infant formula for at least 24 hours.

Exclusion criteria

Exclusion Criteria:

  • History of underlying disease or congenital malformation which, in the opinion of the Investigator, is likely to interfere with the normal growth and development or the evaluation of the mineral absorption of the participant
  • Use of multiple vitamin and mineral supplements prior to enrollment.
  • Evidence of formula intolerance or poor intake at time of randomization
05

Study design

Phase
Not applicable

Study arms

  • Experimental
    Cow milk-based infant formula with prebiotic blend

    Other: Infant Formula

  • Placebo comparator
    Marketed Cow milk-based infant formula

    Other: Infant Formula

Interventions

  • OtherInfant Formula
06

What researchers measure

Primary outcomes

  1. To evaluate the amount of minerals in the urine

Secondary outcomes

  1. Compare the amount of vitamins and minerals in the blood

07

Study locations

5 sites
  • Children's Hospital of Iowa
    Coralville, Iowa 52241, United States
  • Pediatric Clinical Trials Unit
    Louisville, Kentucky 40202, United States
  • The Center for Human Nutrition
    Omaha, Nebraska 68105, United States
  • Cincinnati Children's Hospital Medical Center Clinical Trials Office
    Cincinnati, Ohio 45229, United States
  • Children's Research and Nutrition Center
    Houston, Texas 77030, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01177917
Lead sponsor
Mead Johnson Nutrition
First posted
Aug 9, 2010
Start date
Aug 2006
Primary completion
Sep 2008
Completion
Oct 2008
Last update
Aug 9, 2010

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.

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