Healthy InfantsPhase 3NCT01699386
Growth of Infants Fed an Elemental Medical Food
A Phase 3 study testing Experimental Study Formula in people with Healthy Infants, run by Abbott Nutrition at 2 sites in United States.
Trial summary
Effects on weight will be monitored in healthy infant subjects consuming assigned infant formulas. Read more about this study
- Who is it for?
- Ages Up to 9 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy Infants
- What is being tested?
- Experimental Study Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 1999to Dec 2000
- 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 Up to 9 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Singleton, healthy infant
- Gestational age of 37 to 42 weeks
- Birth weight of 2500 grams or greater
- Age between birth and 9 days of age
- Parents agree to not administer mineral or vitamin supplements during the study period
- Parents agree to feed study formula exclusively for the duration of the study
Who cannot join
- Maternal, fetal or perinatal history which may have adverse effects on growth
- Multiple birth
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Iowa
Iowa City, Iowa, 52242-1083
T&W Research
Little Rock, Arkansas, 72211
About this study
Effects on weight will be monitored in healthy infant subjects consuming assigned infant formulas.
- Conditions
- Healthy Infants
- Being tested
- Control Study Formula, Experimental Study Formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Study FormulaOther
Also called protein hydrolysate formula, Nutramigen
feed as lib
Experimental Study FormulaOther
Also called free-amino acid-based medical food, EleCare
feed as lib
| Study group | Role | What they receive |
|---|---|---|
| Control Study Formula | Active comparator | protein hydrolysate formula Receives: Other: Control Study Formula |
| Experimental Study Formula | Experimental | free-amino acid-based medical food Receives: Other: Experimental Study Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
weight gain during the study period
Measured: 14 days of age to 112 days of age
Secondary outcomes (3)
Anthropometric Measurements
length, head circumference, and length gain
Measured: 14 days of age to 112 days of age
GI Tolerance
daily stool number, stool consistency, formula intake
Measured: At visits 14 and 28
Lab Measurement
serum albumin
Measured: At 112 day visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startApr 1999
- Primary completionDec 2000
- Study completionDec 2000
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 Healthy 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marlene W Borschel, PhD, RD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01699386
- Sponsor's protocol ID
- AH73
- Status last verified
- Oct 2012
- First submitted
- 2 Oct 2012
- Last updated
- 3 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.
PubMed 33006765
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth of Infants Fed an Elemental Medical Food
- ClinicalTrials.gov ID
- NCT01699386
- Acronym / sponsor ID
- AH73
- Conditions
- Healthy Infants
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Apr 1999
- Primary completion
- Dec 2000 (actual)
- Study completion
- Dec 2000 (actual)
- First posted
- 3 Oct 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.
Effects on weight will be monitored in healthy infant subjects consuming assigned infant formulas.
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 |
|---|---|---|
| Control Study Formula | Active comparator | Other: Control Study Formulaprotein hydrolysate formula |
| Experimental Study Formula | Experimental | Other: Experimental Study Formulafree-amino acid-based medical food |
Who may qualify
- Ages
- Up to 9 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Singleton, healthy infant
- Gestational age of 37 to 42 weeks
- Birth weight of 2500 grams or greater
- Age between birth and 9 days of age
- Parents agree to not administer mineral or vitamin supplements during the study period
Key exclusion criteria (2 listed)
- Maternal, fetal or perinatal history which may have adverse effects on growth
- Multiple birth
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 |
|---|---|---|
| Control Study FormulaAlso: protein hydrolysate formula, Nutramigenfeed as lib | Other | Control Study Formula |
| Experimental Study FormulaAlso: free-amino acid-based medical food, EleCarefeed as lib | Other | Experimental Study Formula |
Primary outcome
Weight
Time frame: 14 days of age to 112 days of age
weight gain during the study period
3 secondary outcomes
Anthropometric Measurements
Time frame: 14 days of age to 112 days of age
GI Tolerance
Time frame: At visits 14 and 28
Lab Measurement
Time frame: At 112 day visit
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 3 Oct 2012.
- Derived from this study: PubMed 33006765Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.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, RD 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 3 study testing Experimental Study Formula in people with Healthy Infants, 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 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: finished, as of the sponsor's last update on 3 Oct 2012. 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 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?
Weight (time frame: 14 days of age to 112 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 NCT01699386, 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 3 Oct 2012.