Term InfantsNCT00518414
The Evaluation of Cow Milk-Based Formulas
A study testing Marketed infant formula with DHA and ARA, Milk-based infant formula with DHA and ARA and Milk-based formula with DHA, ARA, prebiotics in people with Term Infants, run by Mead Johnson Nutrition at 9 sites in United States.
Trial summary
Infants will be fed infant formula and blood drawn to measure fatty acid levels in the blood. Read more about this study
- Who is it for?
- Ages 10 to 18 daysHealthy volunteers can take part
- Conditions the study is for
- Term Infants
- What is being tested?
- Marketed infant formula with DHA and ARA, Milk-based infant formula with DHA and ARA and Milk-based formula with DHA, ARA, prebiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 9 sitesUnited States
- Study dates
- Apr 2007to Jan 2008
- Phase
- Interventional
- 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 10 to 18 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy, term infant
- 10 to 18 days of age
Who cannot join
- Breast fed infants
- Infants with formula intolerance
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Birmingham Pediatric Group
Birmingham, Alabama, 35205
Southlake Pediatrics
Birmingham, Alabama, 35244
Welborn Clinic
Evansville, Indiana, 47714
Holston Medical Group
Kingsport, Tennessee, 37660
Arkansas Pediatric Clinic
Little Rock, Arkansas, 72205
DCOL Center for Clinical Research
Longview, Texas, 75605
The Center for Human Nutrition
Omaha, Nebraska, 68105
Children's Medical Association
Tamarac, Florida, 33321
Northwood Pediatrics
The Woodlands, Texas, 77380
About this study
Official title: The Evaluation of Cow Milk-Based Formulas - Study A
Infants will be fed infant formula and blood drawn to measure fatty acid levels in the blood.
- Conditions
- Term Infants
- Being tested
- Marketed infant formula with DHA and ARA, Milk-based infant formula with DHA and ARA, Milk-based formula with DHA, ARA, prebiotics
- Keywords
- infant, formula, LC PUFA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marketed infant formula with DHA and ARAOther
Milk-based infant formula with DHA and ARAOther
Milk-based formula with DHA, ARA, prebioticsOther
| Study group | Role | What they receive |
|---|---|---|
| Marketed infant formula with DHA and ARA | Active comparator | Marketed milk-based infant formula containing docosahexaenoic acid (DHA) and arachidonic acid (ARA) Receives: Other: Marketed infant formula with DHA and ARA |
| Milk-based infant formula with DHA and ARA | Experimental | Experimental milk-based infant formula containing docosahexaenoic acid (DHA) and arachidonic acid (ARA) Receives: Other: Milk-based infant formula with DHA and ARA |
| Milk-based formula with DHA, ARA, prebiotics | Experimental | Experimental milk-based infant formula containing docosahexaenoic acid (DHA) and arachidonic acid (ARA) and prebiotic blend Receives: Other: Milk-based formula with DHA, ARA, prebiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Red Blood Cell (RBC) ARA and DHA
Measured: 120 Days of age
Secondary outcomes (1)
Phospholipid fatty acids, tolerance
Measured: 120 Days of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2007 (estimated)
- Study startApr 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Term 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carol L Berseth, M.D., Study director, Mead Johnson Nutritionals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00518414
- Sponsor's protocol ID
- 3378
- Status last verified
- Sep 2015
- First submitted
- 17 Aug 2007
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Cow Milk-Based Formulas - Study A
- ClinicalTrials.gov ID
- NCT00518414
- Acronym / sponsor ID
- 3378
- Conditions
- Term Infants
- Keywords
- infant, formula, LC PUFA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 20 Aug 2007 (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.
Infants will be fed infant formula and blood drawn to measure fatty acid levels in the blood.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Marketed infant formula with DHA and ARA | Active comparator | Other: Marketed infant formula with DHA and ARAMarketed milk-based infant formula containing docosahexaenoic acid (DHA) and arachidonic acid (ARA) |
| Milk-based infant formula with DHA and ARA | Experimental | Other: Milk-based infant formula with DHA and ARAExperimental milk-based infant formula containing docosahexaenoic acid (DHA) and arachidonic acid (ARA) |
| Milk-based formula with DHA, ARA, prebiotics | Experimental | Other: Milk-based formula with DHA, ARA, prebioticsExperimental milk-based infant formula containing docosahexaenoic acid (DHA) and arachidonic acid (ARA) and prebiotic blend |
Who may qualify
- Ages
- 10 to 18 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Healthy, term infant
- 10 to 18 days of age
Key exclusion criteria (2 listed)
- Breast fed infants
- Infants with formula intolerance
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 |
|---|---|---|
| Marketed infant formula with DHA and ARA | Other | Marketed infant formula with DHA and ARA |
| Milk-based infant formula with DHA and ARA | Other | Milk-based infant formula with DHA and ARA |
| Milk-based formula with DHA, ARA, prebiotics | Other | Milk-based formula with DHA, ARA, prebiotics |
Primary outcome
Red Blood Cell (RBC) ARA and DHA
Time frame: 120 Days of age
1 secondary outcome
Phospholipid fatty acids, tolerance
Time frame: 120 Days of age
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 28 Sep 2015.
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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.
Carol L Berseth, M.D. study director
Mead Johnson Nutritionals
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Marketed infant formula with DHA and ARA, Milk-based infant formula with DHA and ARA and Milk-based formula with DHA, ARA, prebiotics in people with Term Infants, run by Mead Johnson Nutrition at 9 sites in United States.
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 2 inclusion and 2 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 28 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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.
What does the primary outcome measure?
Red Blood Cell (RBC) ARA and DHA (time frame: 120 Days of age). 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 28 Sep 2015.