HealthyPhase 2NCT00465764
Tolerance and Development of Healthy, Term Infants
A Phase 2 study testing Alternate protein infant formula and Standard infant formula in people with Healthy, run by Abbott Nutrition at 2 sites in United States.
Trial summary
To compare the tolerance and early bone status of healthy, term infants fed formulas during the first three months of life. Read more about this study
- Who is it for?
- Ages 1 day to 8 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Alternate protein infant formula and Standard infant formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2007to Jun 2008
- Phase
- Phase 2
- 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 1 day to 8 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy term infants;
- Age 0-8 days of age;
- Exclusively formula fed;
- No use of vitamin/mineral supplements.
Who cannot join
- Maternal, fetal or perinatal medical history thought to have potential for negative effects on tolerance, growth or development.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Nutrition Research Center, Baylor College of Medicine
Houston, Texas, 77030
Midwest Children's Health Research Institute
Lincoln, Nebraska, 68505
About this study
Official title: Pilot Tolerance and Bone Status of Healthy, Term Infants Fed Infant Formulas
To compare the tolerance and early bone status of healthy, term infants fed formulas during the first three months of life.
- Conditions
- Healthy
- Being tested
- Alternate protein infant formula, Standard infant formula
- Keywords
- healthy infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternate protein infant formulaOther
Feed as per HCP directions
Standard infant formulaOther
Feed as per HCP directions
| Study group | Role | What they receive |
|---|---|---|
| Protein formula | Experimental | Feed as per HCP direction Receives: Other: Alternate protein infant formula |
| Standard infant formula | Active comparator | Feed as per HCP instructions Receives: Other: Standard infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean rank stool consistency at 14 days of age
Measured: 14 days of age
Secondary outcomes (1)
Blood chemistries, bone mineral content, percent of feedings with spit-up or vomit associated with feeding
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionApr 2008
- Study completionJun 2008
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 HealthyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Marlene W Borschel, PhD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00465764
- Sponsor's protocol ID
- AK44
- Status last verified
- Jun 2008
- First submitted
- 23 Apr 2007
- Last updated
- 27 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gonzalez-Garay AG, Serralde-Zuniga AE, Medina Vera I, Velasco Hidalgo L, Alonso Ocana MV. Higher versus lower protein intake in formula-fed term infants. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD013758. doi: 10.1002/14651858.CD013758.pub2.
PubMed 37929831
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Tolerance and Bone Status of Healthy, Term Infants Fed Infant Formulas
- ClinicalTrials.gov ID
- NCT00465764
- Acronym / sponsor ID
- AK44
- Conditions
- Healthy
- Keywords
- healthy infants
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 25 Apr 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.
To compare the tolerance and early bone status of healthy, term infants fed formulas during the first three months of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protein formula | Experimental | Other: Alternate protein infant formulaFeed as per HCP direction |
| Standard infant formula | Active comparator | Other: Standard infant formulaFeed as per HCP instructions |
Who may qualify
- Ages
- 1 day to 8 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy term infants;
- Age 0-8 days of age;
- Exclusively formula fed;
- No use of vitamin/mineral supplements.
Key exclusion criteria (1 listed)
- Maternal, fetal or perinatal medical history thought to have potential for negative effects on tolerance, growth or development.
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 |
|---|---|---|
| Alternate protein infant formulaFeed as per HCP directions | Other | Protein formula |
| Standard infant formulaFeed as per HCP directions | Other | Standard infant formula |
Primary outcome
Mean rank stool consistency at 14 days of age
Time frame: 14 days of age
1 secondary outcome
Blood chemistries, bone mineral content, percent of feedings with spit-up or vomit associated with feeding
Time frame: 14 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 27 Apr 2009.
- Derived from this study: PubMed 37929831Gonzalez-Garay AG, Serralde-Zuniga AE, Medina Vera I, Velasco Hidalgo L, Alonso Ocana MV. Higher versus lower protein intake in formula-fed term infants. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD013758. doi: 10.1002/14651858.CD013758.pub2.
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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.
Marlene W Borschel, PhD study chair
Abbott Nutrition
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alternate protein infant formula and Standard infant formula in people with Healthy, run by Abbott Nutrition at 2 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 4 inclusion and 1 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 27 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Mean rank stool consistency at 14 days of age (time frame: 14 days of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00465764, 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 27 Apr 2009.