Healthy Term Infants Solely Formula FedNCT00666120
Assessment of Feeding Tolerance in Infants Fed Cow Milk Formula
A study testing Enfamil LIPIL with iron and Good Start Supreme with DHA and ARA in people with Healthy Term Infants Solely Formula Fed, run by Mead Johnson Nutrition at 18 sites in United States.
Trial summary
To compare the number of infants who discontinue from study formula due to formula intolerance as documented by the investigator. Hypothesize there will be no difference between formula groups. Read more about this study
- Who is it for?
- Ages 4 to 18 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy Term Infants Solely Formula Fed
- What is being tested?
- Enfamil LIPIL with iron and Good Start Supreme with DHA and ARA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 333 participants
- Where
- 18 sitesUnited States
- Study dates
- Jun 2005to Apr 2006
- 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 4 to 18 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Singleton birth
- Term infant at birth
- Birth weight of 2500 g (5 lbs 8 oz) or more
- 4 - 18 days of age at Study Visit 1
Who cannot join
- History of underlying metabolic or chronic disease or congenital malformation
- Infant switched formulas more than one time between birth and Study Visit 1
- Known feeding problems at Study Visit 1
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Arklatex Children's Center
Bossier City, Louisiana, 71111
Craig Spiegel, MD
Bridgeton, Missouri, 63044
Cary Pediatric Center
Cary, North Carolina, 27511
Tampa Bay Medical Research
Clearwater, Florida, 33761
Children's Health Care
DeKalb, Illinois, 60115
Welborn Clinic
Evansville, Indiana, 47714
Fomon Infant Nutrition Unit
Iowa City, Iowa, 52242
Harvey Pediatrics
Jonesboro, Arkansas, 22401
Pediatrics Clinical Trials Unit
Louisville, Kentucky, 40202
Winthrop Pediatric Associates
Mineola, New York, 11501
The Center for Human Nutrition
Omaha, Nebraska, 68105
Boystown
Omaha, Nebraska, 68124
Pedia Research
Owensboro, Kentucky, 42301
Mercy Rogers Pediatric Clinic
Rogers, Arkansas, 72756
Lovelace Scientific Resources
Santa Ana, California, 92704
Children's Medical Association
Tamarac, Florida, 33321
Collom and Carney Clinic
Texarkana, Texas, 75503
Heartland Research Associates
Wichita, Kansas, 67207
About this study
To compare the number of infants who discontinue from study formula due to formula intolerance as documented by the investigator.
Hypothesize there will be no difference between formula groups.
- Conditions
- Healthy Term Infants Solely Formula Fed
- Being tested
- Enfamil LIPIL with iron, Good Start Supreme with DHA and ARA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enfamil LIPIL with ironOther
cow's milk based infant formula
Good Start Supreme with DHA and ARAOther
partially hydrolzed cow's milk protein
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Cow's milk based infant formula Receives: Other: Enfamil LIPIL with iron |
| 2 | Active comparator | Partially hydrolyzed cow's milk based infant formula Receives: Other: Good Start Supreme with DHA and ARA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of infants who discontinue from study formula due to formula intolerance as documented by the investigator
Measured: 60 days
Secondary outcomes (1)
Infant temperament
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startJun 2005
- Primary completionApr 2006
- Study completionApr 2006
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 Infants Solely Formula FedStudies 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
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Carol Berseth, MD, Study director, Mead Johnson Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666120
- Sponsor's protocol ID
- 3370-6
- Status last verified
- Apr 2008
- First submitted
- 22 Apr 2008
- Last updated
- 24 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Berseth CL, Mitmesser SH, Ziegler EE, Marunycz JD, Vanderhoof J. Tolerance of a standard intact protein formula versus a partially hydrolyzed formula in healthy, term infants. Nutr J. 2009 Jun 19;8:27. doi: 10.1186/1475-2891-8-27.
PubMed 19545360
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Feeding Tolerance in Infants Fed Cow Milk Formula
- ClinicalTrials.gov ID
- NCT00666120
- Acronym / sponsor ID
- 3370-6
- Conditions
- Healthy Term Infants Solely Formula Fed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 24 Apr 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.
To compare the number of infants who discontinue from study formula due to formula intolerance as documented by the investigator.
Hypothesize there will be no difference between formula groups.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Enfamil LIPIL with ironCow's milk based infant formula |
| 2 | Active comparator | Other: Good Start Supreme with DHA and ARAPartially hydrolyzed cow's milk based infant formula |
Who may qualify
- Ages
- 4 to 18 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Singleton birth
- Term infant at birth
- Birth weight of 2500 g (5 lbs 8 oz) or more
- 4 - 18 days of age at Study Visit 1
Key exclusion criteria (3 listed)
- History of underlying metabolic or chronic disease or congenital malformation
- Infant switched formulas more than one time between birth and Study Visit 1
- Known feeding problems at Study Visit 1
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 |
|---|---|---|
| Enfamil LIPIL with ironcow's milk based infant formula | Other | 1 |
| Good Start Supreme with DHA and ARApartially hydrolzed cow's milk protein | Other | 2 |
Primary outcome
Number of infants who discontinue from study formula due to formula intolerance as documented by the investigator
Time frame: 60 days
1 secondary outcome
Infant temperament
Time frame: 60 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 24 Apr 2008.
- Derived from this study: PubMed 19545360Berseth CL, Mitmesser SH, Ziegler EE, Marunycz JD, Vanderhoof J. Tolerance of a standard intact protein formula versus a partially hydrolyzed formula in healthy, term infants. Nutr J. 2009 Jun 19;8:27. doi: 10.1186/1475-2891-8-27.
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 Berseth, MD study director
Mead Johnson Nutrition
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enfamil LIPIL with iron and Good Start Supreme with DHA and ARA in people with Healthy Term Infants Solely Formula Fed, run by Mead Johnson Nutrition at 18 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 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 24 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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?
Number of infants who discontinue from study formula due to formula intolerance as documented by the investigator (time frame: 60 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 NCT00666120, 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 24 Apr 2008.