GrowthNCT02481531
Growth and Tolerance of Cow's Milk-Based Infant Formulas
A study testing Previously marketed infant formula and Previously marketed formula using a similar protein in people with Growth, run by Mead Johnson Nutrition at 22 sites in United States.
Trial summary
This clinical trial will evaluate the growth, tolerance, and iron status of infants who consume an investigational infant formula containing a nutrient-rich whey protein compared to a previously marketed infant formula. Read more about this study
- Who is it for?
- Ages 10 to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Growth
- What is being tested?
- Previously marketed infant formula and Previously marketed formula using a similar protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 373 participants
- Where
- 22 sitesUnited States
- Study dates
- Jul 2015to 15 Dec 2016
- 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 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Singleton, 10-14 days of age at randomization
- Term infant with birth weight of a minimum of 2500 grams
- Solely formula fed
- Signed Informed Consent and Protected Health Information
Who cannot join
- Anemia at time of birth
- Current use of iron or iron-containing supplements
- History of underlying metabolic or chronic disease or immunocompromised
- Feeding difficulties or formula intolerance
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Children's Research, LLC
Altamonte Springs, Florida, 32701
Heartland Research Associates, LLC
Augusta, Kansas, 67010
Kentucky Pediatrics/Adult Research
Bardstown, Kentucky, 40004
Birmingham Pediatric Associates
Birmingham, Alabama, 35205
Coastal Pediatric Research
Charleston, South Carolina, 29414
Pediatric Associates of Mt. Carmel, Inc
Cincinnati, Ohio, 45245
Ohio Pediatric Research Association
Dayton, Ohio, 45414
Southeastern Pediatric Associates
Dothan, Alabama, 36305
Deaconess Clinical Research
Evansville, Indiana, 47725
Pediatric Associates of Fairfield, Inc.
Fairfield, Ohio, 45014
Northwest Arkansas Pediatric Clinic
Fayetteville, Arkansas, 72703
The Jackson Clinic - North Jackson
Jackson, Tennessee, 38305
The Children's Clinic of Jonesboro, P.A.
Jonesboro, Arkansas, 72401
Holston Medical Group
Kingsport, Tennessee, 37660
DCOL Center for Clinical Research
Longview, Texas, 75605
Heartland Research Associates, LLC
Newton, Kansas, 67114
Norwich Pediatric Group, P.C.
Norwich, Connecticut, 06360
Owensboro Pediatrics
Owensboro, Kentucky, 42303
Pediatrics East - Alabama Clinical Therapeutics
Pinson, Alabama, 35126
UHMP Comprehensive Pediatrics
Westlake, Ohio, 44145
Heartland Research Associates, LLC
Wichita, Kansas, 67205
Woburn Pediatic Associates
Woburn, Massachusetts, 01801
About this study
This clinical trial will evaluate the growth, tolerance, and iron status of infants who consume an investigational infant formula containing a nutrient-rich whey protein compared to a previously marketed infant formula.
- Conditions
- Growth
- Being tested
- Previously marketed infant formula, Previously marketed formula using a similar protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Previously marketed infant formulaOther
Previously marketed formula using a similar proteinOther
| Study group | Role | What they receive |
|---|---|---|
| Previously marketed infant formula | Active comparator | Cow's milk-based infant formula Receives: Other: Previously marketed infant formula |
| Previously marketed formula using a similar protein | Experimental | Cow's milk-based infant formula Receives: Other: Previously marketed formula using a similar protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight measured at each study visit
Measurement collected with a calibrated infant scale
Measured: 12 months
Secondary outcomes (6)
Body length measured at each study visit
Measurement collected with a standardized length board
Measured: 12 months
Head circumference measured at each study visit
Measurement collected with a standardized measuring tape
Measured: 12 months
Parental recall of study formula intake at each study visit
Measured: 12 months
Parental recall of stool consistency measured at each study visit
Measured: 12 months
Blood Collection
Composite measure of hemoglobin, hematocrit, ferritin, and c-reactive protein
Measured: Once at 12 months
Medically-confirmed adverse events collected throughout the study period
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study startJul 2015
- Primary completion15 Dec 2016
- Study completion15 Dec 2016
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 GrowthStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 373 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Wu, M.D., Study director, Mead Johnson and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02481531
- Sponsor's protocol ID
- 3387-1
- Status last verified
- Mar 2017
- First submitted
- 19 Jun 2015
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
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 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth and Tolerance of Cow's Milk-Based Infant Formulas
- ClinicalTrials.gov ID
- NCT02481531
- Acronym / sponsor ID
- 3387-1
- Conditions
- Growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 373 participants (actual)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- 15 Dec 2016 (actual)
- Study completion
- 15 Dec 2016 (actual)
- First posted
- 25 Jun 2015 (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 clinical trial will evaluate the growth, tolerance, and iron status of infants who consume an investigational infant formula containing a nutrient-rich whey protein compared to a previously marketed infant formula.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Previously marketed infant formula | Active comparator | Other: Previously marketed infant formulaCow's milk-based infant formula |
| Previously marketed formula using a similar protein | Experimental | Other: Previously marketed formula using a similar proteinCow's milk-based infant formula |
Who may qualify
- Ages
- 10 to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Singleton, 10-14 days of age at randomization
- Term infant with birth weight of a minimum of 2500 grams
- Solely formula fed
- Signed Informed Consent and Protected Health Information
Key exclusion criteria (4 listed)
- Anemia at time of birth
- Current use of iron or iron-containing supplements
- History of underlying metabolic or chronic disease or immunocompromised
- Feeding difficulties or 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 |
|---|---|---|
| Previously marketed infant formula | Other | Previously marketed infant formula |
| Previously marketed formula using a similar protein | Other | Previously marketed formula using a similar protein |
Primary outcome
Body weight measured at each study visit
Time frame: 12 months
Measurement collected with a calibrated infant scale
6 secondary outcomes
Body length measured at each study visit
Time frame: 12 months
Head circumference measured at each study visit
Time frame: 12 months
Parental recall of study formula intake at each study visit
Time frame: 12 months
Parental recall of stool consistency measured at each study visit
Time frame: 12 months
Blood Collection
Time frame: Once at 12 months
Medically-confirmed adverse events collected throughout the study period
Time frame: 12 months
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 Mar 2017.
- 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.
Steven Wu, M.D. study director
Mead Johnson and Company
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Previously marketed infant formula and Previously marketed formula using a similar protein in people with Growth, run by Mead Johnson Nutrition at 22 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 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 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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?
Body weight measured at each study visit (time frame: 12 months). 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 NCT02481531, 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 Mar 2017.