Healthy Term InfantPhase 3NCT01617889
Healthy Term Infants Fed Milk-Based Formulas
A Phase 3 study testing Experimental powdered milk-based infant formula with an alternate fat blend and A powdered milk-based infant formula, standard fat blend in people with Healthy Term Infant, run by Abbott Nutrition at 1 site in United States.
Trial summary
The objective is to assess the comparative fat and calcium absorption, and gastrointestinal (GI) tolerance in healthy normal term infants fed powdered milk-based formulas containing different fat blends. Read more about this study
- Who is it for?
- Ages 53 to 115 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy Term Infant
- What is being tested?
- Experimental powdered milk-based infant formula with an alternate fat blend and A powdered milk-based infant formula, standard fat blend
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Aug 2012
- Phase
- Phase 3
- 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 53 to 115 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infant is judged to be in good health.
- Infant is singleton from a full term birth
- Infant's birth weight was > 2490 g.
- Infant is between 53 and 115 days of age
- Infant is on infant formula and tolerating infant formula feedings
- Parent(s) confirm they will not administer vitamin or mineral supplements, solid foods or juices for the duration of the study, unless instructed otherwise by their healthcare professional.
- Parent(s) and physician agree to discontinue the use of medications or home remedies, herbal preparations that might affect GI tolerance
Who cannot join
- Infant has received human milk within 7 days prior to SDay 1.
- Any adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development and includes maternal substance abuse
- Infant has been treated with antibiotics within 5 days prior to SDay 1
- Infant has received probiotics within 5 days prior to SDay 1.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
Official title: Healthy Term Infants Fed Milk-Based Formulas With Different Fat Blends
The objective is to assess the comparative fat and calcium absorption, and gastrointestinal (GI) tolerance in healthy normal term infants fed powdered milk-based formulas containing different fat blends.
- Conditions
- Healthy Term Infant
- Being tested
- Experimental powdered milk-based infant formula with an alternate fat blend, A powdered milk-based infant formula, standard fat blend
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental powdered milk-based infant formula with an alternate fat blendOther
formula to be consumed ad lib
A powdered milk-based infant formula, standard fat blendOther
formula to be consumed ad lib
| Study group | Role | What they receive |
|---|---|---|
| Powdered milk-based formula, standard fat blend | Active comparator | Not described Receives: Other: A powdered milk-based infant formula, standard fat blend |
| Powder milk-based formula, alternate fat blend | Experimental | Not described Receives: Other: Experimental powdered milk-based infant formula with an alternate fat blend |
What is being measured
The primary outcome is the main question the study is designed to answer.
calcium absorption
as measured in stool
Measured: 8 days
Secondary outcomes (4)
stool consistency
measured on 5 point scale
Measured: 28 days
fat absorption
as measured in stool
Measured: 8 days
average number of stools per day
Measured: 28 days
percent of feedings with spit up/vomit associated with feeding per day.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startMar 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Term InfantStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Lasekan, PhD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01617889
- Sponsor's protocol ID
- AK88
- Status last verified
- Feb 2013
- First submitted
- 10 Jun 2012
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Term Infants Fed Milk-Based Formulas With Different Fat Blends
- ClinicalTrials.gov ID
- NCT01617889
- Acronym / sponsor ID
- AK88
- Conditions
- Healthy Term Infant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 13 Jun 2012 (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.
The objective is to assess the comparative fat and calcium absorption, and gastrointestinal (GI) tolerance in healthy normal term infants fed powdered milk-based formulas containing different fat blends.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Powdered milk-based formula, standard fat blend | Active comparator | Other: A powdered milk-based infant formula, standard fat blend |
| Powder milk-based formula, alternate fat blend | Experimental | Other: Experimental powdered milk-based infant formula with an alternate fat blend |
Who may qualify
- Ages
- 53 to 115 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Infant is judged to be in good health.
- Infant is singleton from a full term birth
- Infant's birth weight was > 2490 g.
- Infant is between 53 and 115 days of age
- Infant is on infant formula and tolerating infant formula feedings
Key exclusion criteria (4 listed)
- Infant has received human milk within 7 days prior to SDay 1.
- Any adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development and includes maternal substance abuse
- Infant has been treated with antibiotics within 5 days prior to SDay 1
- Infant has received probiotics within 5 days prior to SDay 1.
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 |
|---|---|---|
| Experimental powdered milk-based infant formula with an alternate fat blendformula to be consumed ad lib | Other | Powder milk-based formula, alternate fat blend |
| A powdered milk-based infant formula, standard fat blendformula to be consumed ad lib | Other | Powdered milk-based formula, standard fat blend |
Primary outcome
calcium absorption
Time frame: 8 days
as measured in stool
4 secondary outcomes
stool consistency
Time frame: 28 days
fat absorption
Time frame: 8 days
average number of stools per day
Time frame: 28 days
percent of feedings with spit up/vomit associated with feeding per day.
Time frame: 28 days
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 15 Feb 2013.
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A Clinical Trial on the Effect of Infant Formula Consumption on Growth, Immune Parameters, and Gut Health in Healthy Term Infants
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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 Lasekan, PhD study chair
Abbott Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Experimental powdered milk-based infant formula with an alternate fat blend and A powdered milk-based infant formula, standard fat blend in people with Healthy Term Infant, run by Abbott Nutrition at 1 site 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 7 inclusion and 4 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 15 Feb 2013. 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 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
calcium absorption (time frame: 8 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 15 Feb 2013.