Healthy Term InfantsNCT00712608
The Evaluation of Cow's Milk Formula - Study B
A study testing Infant formula and Cow's milk infant formula in people with Healthy Term Infants, run by Mead Johnson Nutrition at 22 sites in United States.
Trial summary
A study to evaluate the growth and development of term infants fed either a marketed cow's milk formula, or an experimental cow's milk formula with prebiotics + a different calcium source + a different level of fatty acids and fat, or an experimental cow's milk formula with prebiotic + a different calcium source + a… Read more about this study
- Who is it for?
- Ages 12 to 16 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy Term Infants
- What is being tested?
- Infant formula and Cow's milk infant formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 399 participants
- Where
- 22 sitesUnited States
- Study dates
- Aug 2008to Oct 2009
- 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 12 to 16 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Term infant
- 12-16 days of age
- 37-42 weeks GA
Who cannot join
- History of chronic disease, congenital malformation
- Feeding difficulties or formula intolerance
- LGA
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Central Arkansas Pediatric Clinic
Benton, Arkansas, 72019
Birmingham Pediatric Group
Birmingham, Alabama, 35205
Retina Foundation of the Southwest
Dallas, Texas, 75231
Alabama Clinical Therapeutics
Dothan, Alabama, 36305
Medical Associates
Fayetteville, Arkansas, 72703
Holston Medical Group, MeadowView Lane
Kingsport, Tennessee, 37660
Holston Medical Group
Kingsport, Tennessee, 37660
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, 72202
Arkansas Pediatric Clinic
Little Rock, Arkansas, 72205
DCOL Center for Clinical Research
Longview, Texas, 75605
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
Odyssey Research
Minot, North Dakota, 58701
Welborn Clinic Research
Newburgh, Indiana, 47630
Southwestern Medical Clinic, PC
Niles, Michigan, 49120
Norwich Pediatric Group, PC
Norwich, Connecticut, 06360
The Center for Human Nutrition
Omaha, Nebraska, 68105
Red Lion Pediatrics
Philadelphia, Pennsylvania, 19114
Primary Physicians Research, Inc
Pittsburgh, Pennsylvania, 15241
Aspen Medical Group
Saint Paul, Minnesota, 55108
Southwestern Medical Clinic, PC
Stevensville, Michigan, 49127
Palm Beach Clinical Investigation, LLC
West Palm Beach, Florida, 33407
Woburn Pediatric Associates Research Department
Woburn, Massachusetts, 01801
About this study
A study to evaluate the growth and development of term infants fed either a marketed cow's milk formula, or an experimental cow's milk formula with prebiotics + a different calcium source + a different level of fatty acids and fat, or an experimental cow's milk formula with prebiotic + a different calcium source + a different level of fatty acids and fat
- Conditions
- Healthy Term Infants
- Being tested
- Infant formula, Cow's milk infant formula
- Keywords
- Term, Infant, Formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant formulaOther
Also called Similar to Enfamil LIPIL with iron
Marketed cow's milk base infant formula 20 kcal/oz
Infant formulaOther
Also called No other similar brand names; experimental formula
cow's milk based infant formula with prebiotics, different level of fatty acids and fat and a different calcium source
Cow's milk infant formulaOther
Also called No other similar brand names; experimental product
Cow's milk based formula with prebiotics, different level of fatty acids and fat and a different calcium source
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Marketed cow's milk-based formula Receives: Other: Infant formula |
| 2 | Experimental | Cow's milk based formula with prebiotics, different level of fatty acids and fat and a different calcium source Receives: Other: Infant formula |
| 3 | Experimental | Cow's milk based formula with prebiotic, different level of fatty acids and fat and a different calcium source Receives: Other: Cow's milk infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of weight gain
Measured: 106 days
Secondary outcomes (1)
length and head circumference
Measured: 106 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2008 (estimated)
- Study startAug 2008
- Primary completionOct 2009
- Study completionOct 2009
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 Term 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 399 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Carol L Berseth, MD, Study director, Mead Johnson & Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00712608
- Sponsor's protocol ID
- 3378-2
- Status last verified
- Apr 2009
- First submitted
- 8 Jul 2008
- Last updated
- 28 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Ashley C, Johnston WH, Harris CL, Stolz SI, Wampler JL, Berseth CL. Growth and tolerance of infants fed formula supplemented with polydextrose (PDX) and/or galactooligosaccharides (GOS): double-blind, randomized, controlled trial. Nutr J. 2012 Jun 7;11:38. doi: 10.1186/1475-2891-11-38.
PubMed 22676715
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Cow's Milk Formula - Study B
- ClinicalTrials.gov ID
- NCT00712608
- Acronym / sponsor ID
- 3378-2
- Conditions
- Healthy Term Infants
- Keywords
- Term, Infant, Formula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 399 participants (estimated)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 10 Jul 2008 (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.
A study to evaluate the growth and development of term infants fed either a marketed cow's milk formula, or an experimental cow's milk formula with prebiotics + a different calcium source + a different level of fatty acids and fat, or an experimental cow's milk formula with prebiotic + a different calcium source + a different level of fatty acids and fat
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Infant formulaMarketed cow's milk-based formula |
| 2 | Experimental | Other: Infant formulaCow's milk based formula with prebiotics, different level of fatty acids and fat and a different calcium source |
| 3 | Experimental | Other: Cow's milk infant formulaCow's milk based formula with prebiotic, different level of fatty acids and fat and a different calcium source |
Who may qualify
- Ages
- 12 to 16 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Term infant
- 12-16 days of age
- 37-42 weeks GA
Key exclusion criteria (3 listed)
- History of chronic disease, congenital malformation
- Feeding difficulties or formula intolerance
- LGA
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 |
|---|---|---|
| Infant formulaAlso: Similar to Enfamil LIPIL with ironMarketed cow's milk base infant formula 20 kcal/oz | Other | 1 |
| Infant formulaAlso: No other similar brand names; experimental formulacow's milk based infant formula with prebiotics, different level of fatty acids and fat and a different calcium source | Other | 2 |
| Cow's milk infant formulaAlso: No other similar brand names; experimental productCow's milk based formula with prebiotics, different level of fatty acids and fat and a different calcium source | Other | 3 |
Primary outcome
Rate of weight gain
Time frame: 106 days
1 secondary outcome
length and head circumference
Time frame: 106 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 28 Jan 2010.
- Derived from this study: PubMed 22676715Ashley C, Johnston WH, Harris CL, Stolz SI, Wampler JL, Berseth CL. Growth and tolerance of infants fed formula supplemented with polydextrose (PDX) and/or galactooligosaccharides (GOS): double-blind, randomized, controlled trial. Nutr J. 2012 Jun 7;11:38. doi: 10.1186/1475-2891-11-38.
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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.
Carol L Berseth, MD study director
Mead Johnson & 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 Infant formula and Cow's milk infant formula in people with Healthy Term Infants, 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 3 inclusion and 3 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 28 Jan 2010. 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?
Rate of weight gain (time frame: 106 days). 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 NCT00712608, 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 28 Jan 2010.