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CompletedNCT01058187Updated Mar 12, 2014

Assessment of Fatty Acids in Infants' Blood Cells When Consuming Infant Formula Containing Long-Chain Polyunsaturated Fatty Acids

An observational study in Levels of Fatty Acids in the Blood Cells of Infants, sponsored by Mead Johnson Nutrition. Completed at 1 site in Canada. Open to participants aged 12 Days to 25 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-03-12.

Sponsored by Mead Johnson Nutrition (part of Reckitt) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
86
Ages
12 Days to 25 Days
Sex
All
01

Study summary

To compare amounts of DHA, ARA, and other fatty acids in the blood cells of infants consuming infant formulas containing differing levels of fatty acids

02

Conditions studied

  • Levels of Fatty Acids in the Blood Cells of Infants
03

In context

Lead sponsor

Mead Johnson Nutrition is the lead sponsor of 58 studies on the registry; 1 is open to participants now.

First submitted before Mead Johnson Nutrition became part of Reckitt.

Browse Mead Johnson Nutrition studies →All Reckitt studies →

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

04

Who can participate

Ages eligible
12 Days to 25 Days
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Infants 12-25 days of age

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Singleton birth
  • 12-25 days of age
  • Gestational age of 37-42 weeks
  • Solely formula fed for at least 24 hours prior to randomization
  • Birth weight 2500 g - 4000 g

Exclusion criteria

Exclusion Criteria:

  • Serious concurrent illness or congenital malformation
  • Systemic or congenital infection
  • Immunocompromised
  • History of intolerance or allergy to cow milk
  • Maternal autoimmune disorder
  • Participation in another clinical study
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
86 participants (estimated)

Groups and cohorts

  • Control

    Marketed cow milk-based infant formula containing DHA and ARA

  • Investigational 1

    Cow milk-based infant formula with differing level of ARA from Control formula

  • Investigational 2

    Cow milk-based infant formula with a differing level of ARA from Control

06

Study locations

1 site
  • Alberta Institute for Human Nutrition, University of Alberta
    Edmonton, Alberta T6G2P5, Canada
07

References and documents

Publications

  • Miklavcic JJ, Larsen BM, Mazurak VC, Scalabrin DM, MacDonald IM, Shoemaker GK, Casey L, Van Aerde JE, Clandinin MT. Reduction of Arachidonate Is Associated With Increase in B-Cell Activation Marker in Infants: A Randomized Trial. J Pediatr Gastroenterol Nutr. 2017 Mar;64(3):446-453. doi: 10.1097/MPG.0000000000001283. PubMed 27276431 ↗
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2010, a primary completion of May 2013 and a completion of Jul 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 26, 2010
First posted
Jan 28, 2010
Start
Feb 2010
Primary completionActual
May 2013
CompletionActual
Jul 2013
Last update
Mar 12, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 12, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01058187
Lead sponsor
Mead Johnson Nutrition
Collaborators
University of Alberta
First posted
Jan 28, 2010
Start date
Feb 2010
Primary completion
May 2013
Completion
Jul 2013
Last update
Mar 12, 2014

Study contacts

Tom Clandinin, Ph.D.
principal investigator · University of Alberta
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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