Child DevelopmentNCT03487094
Growth and Tolerance of Infants Fed Formula for 16 Weeks
A study testing Infant formula in people with Child Development, run by Nature's One at 24 sites in United States.
Trial summary
Growth and Tolerance Trial of Iron-fortified infant formulas Read more about this study
- Who is it for?
- Ages 1 day to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Child Development
- What is being tested?
- Infant formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 24 sitesUnited States
- Study dates
- 18 Jul 2018to 9 Jul 2020
- 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 1 day to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy term infants, 37-42 weeks gestational age
Who cannot join
- Any condition that would negatively impact assessment of growth and tolerance
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Red Lion Pediatrics
Bensalem, Pennsylvania, 19020
Coastal Pediatric Associates
Charleston, South Carolina, 29414
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, 22902
Paramount Research Solutions
College Park, Georgia, 30349
Aventiv Research, Inc
Columbus, Ohio, 43123
Ohio Pediatric Research Association
Dayton, Ohio, 45414
Pediatrics by the Sea
Delray Beach, Florida, 33483
Qualmedica Research
Evansville, Indiana, 47715
Carolina Institute for Clinical Research
Fayetteville, North Carolina, 28304
Altamonte Pediatric Associates
Lake Mary, Florida, 32746
New Horizon Research Center
Miami, Florida, 33175
Gvozden Pediatrics
Millersville, Maryland, 21108
Harris Pediatric Clinic
Newport, Arkansas, 72112
Coastal Pediatric Research
North Charleston, South Carolina, 29406
Norwich Pediatric Group, PC
Norwich, Connecticut, 06360
Qualmedica Research
Owensboro, Kentucky, 43201
Pediatric Partners
Raleigh, North Carolina, 27609
Southwestern Children's Research Associates, PA
San Antonio, Texas, 78229
Searcy Medical Center
Searcy, Arkansas, 72143
Portico Pediatrics
Shreveport, Louisiana, 71105
Piedmont Healthcare
Statesville, North Carolina, 28625
Visions Clinical Research-Tucson
Tucson, Arizona, 85712
Valley Stream Pediatrics_Lashley
Valley Stream, New York, 11580
Cynthia Strieter-Boland, MD
Westlake, Ohio, 44145
About this study
Official title: Growth Monitoring Study of Infants Fed Formula for 16 Weeks
Growth and Tolerance Trial of Iron-fortified infant formulas
Read the detailed description
16 WEEK GROWTH AND TOLERANCE
- Conditions
- Child Development
- Being tested
- Infant formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant formulaOther
Multi-centered, prospective, randomized clinical trial
| Study group | Role | What they receive |
|---|---|---|
| Growth, Tolerance of Infants-Exp | Active comparator | Infant Formula Receives: Other: Infant formula |
| Growth,Tolerance of Infants-Com | Active comparator | Infant Formula Receives: Other: Infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth
Weight Gain
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start18 Jul 2018
- Primary completion9 Jul 2020
- Study completion9 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies 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
- Model description
- Multi-Investigator, Prospective, Randomized Clinical Trial
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nature's One
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert D Murray, MD, Study director, Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487094
- Sponsor's protocol ID
- N1.2018
- Status last verified
- Jul 2020
- First submitted
- 27 Mar 2018
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth Monitoring Study of Infants Fed Formula for 16 Weeks
- ClinicalTrials.gov ID
- NCT03487094
- Acronym / sponsor ID
- N1.2018
- Conditions
- Child Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Nature's OneIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 9 Jul 2020 (actual)
- Study completion
- 9 Jul 2020 (actual)
- First posted
- 3 Apr 2018 (actual)
- 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.
Growth and Tolerance Trial of Iron-fortified infant formulas
Detailed description
16 WEEK GROWTH AND TOLERANCE
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multi-Investigator, Prospective, Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Growth, Tolerance of Infants-Exp | Active comparator | Other: Infant formulaInfant Formula |
| Growth,Tolerance of Infants-Com | Active comparator | Other: Infant formulaInfant Formula |
Who may qualify
- Ages
- 1 day to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy term infants, 37-42 weeks gestational age
Key exclusion criteria (1 listed)
- Any condition that would negatively impact assessment of growth and tolerance
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 formulaMulti-centered, prospective, randomized clinical trial | Other | Growth, Tolerance of Infants-Exp, Growth,Tolerance of Infants-Com |
Primary outcome
Growth
Time frame: 16 weeks
Weight Gain
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 10 Jul 2020.
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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.
Robert D Murray, MD study director
Consultant
24 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 in people with Child Development, run by Nature's One at 24 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 1 inclusion and 1 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 10 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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?
Growth (time frame: 16 weeks). 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 10 Jul 2020.