InfantsNCT02069522
Healthy Term Infants Fed Milk-Based Formulas
A study testing Standard Milk-based Formula Containing Carotenoid and Investigational Milk-based Formula Containing Carotenoid in people with Infants, run by Abbott Nutrition at 6 sites in United States.
Trial summary
This is a prospective, double blind, crossover study in healthy infants randomized to one of two study formulas. The trial will consist of two 21 day study feeding periods separated by a study washout period. Read more about this study
- Who is it for?
- Ages 14 to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Infants
- What is being tested?
- Standard Milk-based Formula Containing Carotenoid and Investigational Milk-based Formula Containing Carotenoid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 6 sitesUnited States
- Study dates
- Feb 2014to Feb 2015
- 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 14 to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infant is in good health
- Infant is a singleton from a full term birth with a gestational age of 37-42 weeks
- Infant's birth weight was > 2490 g (~5 lbs 8 oz)
- Infant is between 14 and 28 days of age
- Parent(s) confirm intention to feed their infant the study product(s) as the sole source of nutrition for the duration of the study
- Parent(s) confirm intention not to administer vitamin or mineral supplements, DHA and ARA supplements, solid foods/juices to their infant from enrollment through the duration of the study
Who cannot join
- An adverse maternal, fetal or infant medical history that has potential for effects on tolerance, growth, and/or development.
- Infants using medications (including OTC), home remedies, herbal preparations, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
MetroHealth Medical Center
Cleveland, Ohio, 44109
Dayton Clinical Research
Dayton, Ohio, 45406
Northpoint Pediatrics
Indianapolis, Indiana, 46256
Midwest Children's Health Research Institute
Lincoln, Nebraska, 68505
Institute of Clinical Research
Mayfield Heights, Ohio, 44143
Tuscon Medical Center
Tuscon, Arizona, 85712
About this study
Official title: Healthy Term Infants Fed Milk-Based Formulas With A Supplemental Carotenoid
This is a prospective, double blind, crossover study in healthy infants randomized to one of two study formulas. The trial will consist of two 21 day study feeding periods separated by a study washout period.
- Conditions
- Infants
- Being tested
- Standard Milk-based Formula Containing Carotenoid, Investigational Milk-based Formula Containing Carotenoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Milk-based Formula Containing CarotenoidOther
Fed ad libitum
Investigational Milk-based Formula Containing CarotenoidOther
Fed ad libitum
| Study group | Role | What they receive |
|---|---|---|
| Standard Milk-based Formula Containing Carotenoid | Active comparator | milk-based ready to feed infant formula Receives: Other: Standard Milk-based Formula Containing Carotenoid |
| Investigational Milk-based Formula Containing Carotenoid | Experimental | investigational milk-based ready to feed infant formula Receives: Other: Investigational Milk-based Formula Containing Carotenoid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carotenoid Concentration
Plasma sample
Measured: Change from Baseline to end of Study Period A (~21 Days)
Secondary outcomes (1)
Carotenoid Concentration
Plasma sample
Measured: Change from Baseline to end Study Periods A (~21 Days) and B (~21 Days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Why it stopped: interim analysis findings
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John B Lasekan, PhD, CCRP, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069522
- Sponsor's protocol ID
- AL13
- Status last verified
- Mar 2015
- First submitted
- 18 Feb 2014
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Term Infants Fed Milk-Based Formulas With A Supplemental Carotenoid
- ClinicalTrials.gov ID
- NCT02069522
- Acronym / sponsor ID
- AL13
- Conditions
- Infants
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: interim analysis findings
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 24 Feb 2014 (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.
This is a prospective, double blind, crossover study in healthy infants randomized to one of two study formulas. The trial will consist of two 21 day study feeding periods separated by a study washout period.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Milk-based Formula Containing Carotenoid | Active comparator | Other: Standard Milk-based Formula Containing Carotenoidmilk-based ready to feed infant formula |
| Investigational Milk-based Formula Containing Carotenoid | Experimental | Other: Investigational Milk-based Formula Containing Carotenoidinvestigational milk-based ready to feed infant formula |
Who may qualify
- Ages
- 14 to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Infant is in good health
- Infant is a singleton from a full term birth with a gestational age of 37-42 weeks
- Infant's birth weight was > 2490 g (~5 lbs 8 oz)
- Infant is between 14 and 28 days of age
- Parent(s) confirm intention to feed their infant the study product(s) as the sole source of nutrition for the duration of the study
Key exclusion criteria (2 listed)
- An adverse maternal, fetal or infant medical history that has potential for effects on tolerance, growth, and/or development.
- Infants using medications (including OTC), home remedies, herbal preparations, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance
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 |
|---|---|---|
| Standard Milk-based Formula Containing CarotenoidFed ad libitum | Other | Standard Milk-based Formula Containing Carotenoid |
| Investigational Milk-based Formula Containing CarotenoidFed ad libitum | Other | Investigational Milk-based Formula Containing Carotenoid |
Primary outcome
Carotenoid Concentration
Time frame: Change from Baseline to end of Study Period A (~21 Days)
Plasma sample
1 secondary outcome
Carotenoid Concentration
Time frame: Change from Baseline to end Study Periods A (~21 Days) and B (~21 Days)
Results and safety
The study was stopped early (reason given: interim analysis findings). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 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.
John B Lasekan, PhD, CCRP study chair
Abbott Nutrition
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Milk-based Formula Containing Carotenoid and Investigational Milk-based Formula Containing Carotenoid in people with Infants, run by Abbott Nutrition at 6 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 6 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: stopped early, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 was stopped early (reason given: interim analysis findings). Results are not available in the source record.
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?
Carotenoid Concentration (time frame: Change from Baseline to end of Study Period A (~21 Days)). 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 24 Mar 2015; AzTrials last refreshed its copy on 29 Oct 2026.