GrowthNCT02860026
Growth and Tolerance of Healthy Term Infants Fed Cow's Milk-Based Infant Formulas
A study testing Marketed cow's milk-based infant formula and Cow's milk-based infant formula with added nutrients in people with Growth, run by Mead Johnson Nutrition at 17 sites in United States.
Trial summary
This clinical trial will compare the growth and tolerance of infants who consume an investigational cow's milk-based infant formula to those who consume a marketed cow's milk-based infant formula through approximately 4 months of age. 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?
- Marketed cow's milk-based infant formula and Cow's milk-based infant formula with added nutrients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 17 sitesUnited States
- Study dates
- Oct 2016to Apr 2018
- 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 minimum of 2500 grams
- Solely formula fed
- Signed informed consent and protected health information
Who cannot join
- History of underlying metabolic or chronic disease, anemia, or immune compromise
- Feeding difficulties or formula intolerance
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
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
Altamonte Pediatric Associates
Lake Mary, Florida, 32746
DCOL Center for Clinical Research
Longview, Texas, 75605
Norwich Pediatric Group, P.C.
Norwich, Connecticut, 06360
Owensboro Pediatrics
Owensboro, Kentucky, 42303
UHMP Comprehensive Pediatrics
Westlake, Ohio, 44145
About this study
This clinical trial will compare the growth and tolerance of infants who consume an investigational cow's milk-based infant formula to those who consume a marketed cow's milk-based infant formula through approximately 4 months of age.
- Conditions
- Growth
- Being tested
- Marketed cow's milk-based infant formula, Cow's milk-based infant formula with added nutrients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marketed cow's milk-based infant formulaOther
Cow's milk-based infant formula with added nutrientsOther
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Marketed cow's milk-based infant formula Receives: Other: Marketed cow's milk-based infant formula |
| Investigational | Experimental | Cow's milk-based infant formula with added nutrients Receives: Other: Cow's milk-based infant formula with added nutrients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of body weight gain from 14 to 120 days of age
Measured: 3.5 months
Secondary outcomes (6)
Recall of infant formula at each study visit
Measured: Up to 3.5 months
Body length measured at each study visit
Measured: Up to 3.5 months
Recall of stool characteristics questionnaire measured at each study visit
Measured: Up to 3.5 months
Head circumference measured at each study visit
Measured: Up to 3.5 months
Recall of gastrointestinal tolerance questionnaire at each study visit
Measured: Up to 3.5 months
Medically confirmed adverse events collected throughout the study period
Measured: Up to 3.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startOct 2016
- Primary completionMar 2018 (estimated)
- Study completionApr 2018 (estimated)
Why it stopped: Raw ingredient shortage. Future study start date - TBD
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Wu, Study director, Mead Johnson Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02860026
- Sponsor's protocol ID
- 3388-1
- Status last verified
- May 2017
- First submitted
- 3 Aug 2016
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth and Tolerance of Healthy Term Infants Fed Cow's Milk-Based Infant Formulas
- ClinicalTrials.gov ID
- NCT02860026
- Acronym / sponsor ID
- 3388-1
- Conditions
- Growth
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Raw ingredient shortage. Future study start date - TBD
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Study start
- Oct 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 9 Aug 2016 (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 compare the growth and tolerance of infants who consume an investigational cow's milk-based infant formula to those who consume a marketed cow's milk-based infant formula through approximately 4 months of age.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Marketed cow's milk-based infant formulaMarketed cow's milk-based infant formula |
| Investigational | Experimental | Other: Cow's milk-based infant formula with added nutrientsCow's milk-based infant formula with added nutrients |
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 minimum of 2500 grams
- Solely formula fed
- Signed informed consent and protected health information
Key exclusion criteria (2 listed)
- History of underlying metabolic or chronic disease, anemia, or immune compromise
- 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 |
|---|---|---|
| Marketed cow's milk-based infant formula | Other | Control |
| Cow's milk-based infant formula with added nutrients | Other | Investigational |
Primary outcome
Rate of body weight gain from 14 to 120 days of age
Time frame: 3.5 months
6 secondary outcomes
Recall of infant formula at each study visit
Time frame: Up to 3.5 months
Body length measured at each study visit
Time frame: Up to 3.5 months
Recall of stool characteristics questionnaire measured at each study visit
Time frame: Up to 3.5 months
Head circumference measured at each study visit
Time frame: Up to 3.5 months
Recall of gastrointestinal tolerance questionnaire at each study visit
Time frame: Up to 3.5 months
Medically confirmed adverse events collected throughout the study period
Time frame: Up to 3.5 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Individual participant dataSharing planned: No
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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 study director
Mead Johnson Nutrition
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Marketed cow's milk-based infant formula and Cow's milk-based infant formula with added nutrients in people with Growth, run by Mead Johnson Nutrition at 17 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 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: withdrawn, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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 withdrawn before enrolling participants, so there are no results.
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?
Rate of body weight gain from 14 to 120 days of age (time frame: 3.5 months). 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 31 May 2017.