Levels of Fatty Acids in the Blood Cells of InfantsNCT01058187
Assessment of Fatty Acids in Infants' Blood Cells When Consuming Infant Formula Containing Long-Chain Polyunsaturated Fatty Acids
An observational study of Levels of Fatty Acids in the Blood Cells of Infants, run by Mead Johnson Nutrition at 1 site in Canada.
Trial 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 Read more about this study
- Who is it for?
- Ages 12 to 25 daysHealthy volunteers can take part
- Conditions the study is for
- Levels of Fatty Acids in the Blood Cells of Infants
- How many people
- 86 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2010to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 25 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants 12-25 days of age
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Alberta Institute for Human Nutrition, University of Alberta
Edmonton, Alberta, T6G2P5
About this study
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionMay 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Levels of Fatty Acids in the Blood Cells of InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Alberta
- Investigators
- Tom Clandinin, Ph.D., Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01058187
- Sponsor's protocol ID
- 6000
- Status last verified
- Mar 2014
- First submitted
- 26 Jan 2010
- Last updated
- 12 Mar 2014
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Fatty Acids in Infants' Blood Cells When Consuming Infant Formula Containing Long-Chain Polyunsaturated Fatty Acids
- ClinicalTrials.gov ID
- NCT01058187
- Acronym / sponsor ID
- 6000
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Collaborators
- University of Alberta
- Study start
- Feb 2010
- Primary completion
- May 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 28 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 12 to 25 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants 12-25 days of age
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Serious concurrent illness or congenital malformation
- Systemic or congenital infection
- Immunocompromised
- History of intolerance or allergy to cow milk
- Maternal autoimmune disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2014.
- Derived from this study: PubMed 27276431Miklavcic 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Clandinin, Ph.D. principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Levels of Fatty Acids in the Blood Cells of Infants, run by Mead Johnson Nutrition at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01058187, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2014.