Focus: Nutritional Requirements for InfantsPhase 1NCT02092857
Assessment of Arachidonic Acid Supplementation in Infant Formula on the Immune Response of Infants
A Phase 1 study testing Arachidonic acid (25 mg/100 kcal ) and Arachidonic acid (34 mg/100 kcal) in people with Focus: Nutritional Requirements for Infants, run by University of Alberta at 1 site in Canada.
Trial summary
The immune system of newborn infants is immature with low activity of both innate and acquired immune reactions. Early nutrition has an impact on early immune responses. Dietary fatty acids are one nutritional factor noted to play a role in immune function. Read more about this study
- Who is it for?
- Ages 14 to 21 daysHealthy volunteers can take part
- Conditions the study is for
- Focus: Nutritional Requirements for Infants
- What is being tested?
- Arachidonic acid (25 mg/100 kcal ) and Arachidonic acid (34 mg/100 kcal)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2009to Feb 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 to 21 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy term infants
- birth weight, length and head circumference between the 5th and 95th percentile for gestational age (according to the National Center for Health Statistics growth charts)
- receiving >80% for their intake by mouth from commercial infant formula
- low-risk for allergy based on a negative family history.
Who cannot join
- corticosteroid use
- red cell or plasma transfusions
- IV lipid emulsions prior to study entry
- major congenital malformations
- systemic or congenital infection
- significant neonatal morbidity
- maternal autoimmune disorders
- acute illness precluding oral feedings or conditions requiring feedings other than standard formula
Trial locations and contacts
1 site in 1 country.
About this study
The immune system of newborn infants is immature with low activity of both innate and acquired immune reactions. Early nutrition has an impact on early immune responses. Dietary fatty acids are one nutritional factor noted to play a role in immune function. The omega-6 long-chain polyunsaturated fatty acid, ARA (Arachidonic acid) and the omega-3 fatty acid, DHA (docosahexaenoic acid) are found naturally in breastmilk and some infant formulas. The balance or relative amounts of ARA and DHA have been associated with immune response. Some commercial infant formula contains both ARA and DHA. However, the optimal balance of ARA and DHA has not been determined with respect to immune function. This study will assess two levels of ARA and the impact on immune response in healthy, term infants and whether genes that influence essential fatty acid metabolism alter the nutritional requirement of infants.
- Being tested
- Arachidonic acid (25 mg/100 kcal ), Arachidonic acid (34 mg/100 kcal), Placebo
- Keywords
- nutrient, nutrition, arachidonic acid, essential fatty acids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arachidonic acid (25 mg/100 kcal )Dietary supplement
Arachidonic acid (34 mg/100 kcal)Dietary supplement
PlaceboDietary supplement
10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).
| Study group | Role | What they receive |
|---|---|---|
| 34 mg/100 kcal arachidonic acid | Active comparator | 10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid Receives: Dietary Supplement: Arachidonic acid (34 mg/100 kcal) |
| 25 mg/100 kcal arachidonic acid | Active comparator | 10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid Receives: Dietary Supplement: Arachidonic acid (25 mg/100 kcal ) |
| Infant formula without arachidonic acid | Placebo comparator | 10 weeks exclusive infant formula feeding (without supplemental arachidonic acid). Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Antigen-presenting B Cells
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startDec 2009
- Primary completionNov 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Focus: Nutritional Requirements for InfantsStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Mead Johnson Nutrition
- Responsible party
- Sponsor
- Investigators
- Michael T Clandinin, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092857
- Sponsor's protocol ID
- Pro00005583
- Other IDs
- 230831
- Status last verified
- Mar 2014
- First submitted
- 18 Mar 2014
- Last updated
- 25 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Arachidonic Acid Supplementation in Infant Formula on the Immune Response of Infants
- ClinicalTrials.gov ID
- NCT02092857
- Acronym / sponsor ID
- Pro00005583
- Keywords
- nutrient, nutrition, arachidonic acid, essential fatty acids
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Mead Johnson Nutrition
- Study start
- Dec 2009
- Primary completion
- Nov 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 20 Mar 2014 (estimated)
- Results
- Posted 25 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The immune system of newborn infants is immature with low activity of both innate and acquired immune reactions. Early nutrition has an impact on early immune responses. Dietary fatty acids are one nutritional factor noted to play a role in immune function. The omega-6 long-chain polyunsaturated fatty acid, ARA (Arachidonic acid) and the omega-3 fatty acid, DHA (docosahexaenoic acid) are found naturally in breastmilk and some infant formulas. The balance or relative amounts of ARA and DHA have been associated with immune response. Some commercial infant formula contains both ARA and DHA. However, the optimal balance of ARA and DHA has not been determined with respect to immune function. This study will assess two levels of ARA and the impact on immune response in healthy, term infants and whether genes that influence essential fatty acid metabolism alter the nutritional requirement of infants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 34 mg/100 kcal arachidonic acid | Active comparator | Dietary Supplement: Arachidonic acid (34 mg/100 kcal)10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid |
| 25 mg/100 kcal arachidonic acid | Active comparator | Dietary Supplement: Arachidonic acid (25 mg/100 kcal )10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid |
| Infant formula without arachidonic acid | Placebo comparator | Dietary Supplement: Placebo10 weeks exclusive infant formula feeding (without supplemental arachidonic acid). |
Who may qualify
- Ages
- 14 to 21 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- healthy term infants
- birth weight, length and head circumference between the 5th and 95th percentile for gestational age (according to the National Center for Health Statistics growth charts)
- receiving >80% for their intake by mouth from commercial infant formula
- low-risk for allergy based on a negative family history.
Key exclusion criteria (8 listed)
- corticosteroid use
- red cell or plasma transfusions
- IV lipid emulsions prior to study entry
- major congenital malformations
- systemic or congenital infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arachidonic acid (25 mg/100 kcal ) | Dietary supplement | 25 mg/100 kcal arachidonic acid |
| Arachidonic acid (34 mg/100 kcal) | Dietary supplement | 34 mg/100 kcal arachidonic acid |
| Placebo10 weeks exclusive infant formula feeding (without supplemental arachidonic acid). | Dietary supplement | Infant formula without arachidonic acid |
Primary outcome
Number of Antigen-presenting B Cells
Time frame: 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Michael T Clandinin, PhD 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?
A Phase 1 study testing Arachidonic acid (25 mg/100 kcal ) and Arachidonic acid (34 mg/100 kcal) in people with Focus: Nutritional Requirements for Infants, run by University of Alberta 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 4 inclusion and 8 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 25 Apr 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Number of Antigen-presenting B Cells (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2014.