GrowthNCT01497314
Growth and Safety of a Low Lactose Milk-Based Infant Formula
A study testing Low Lactose Infant Formula in people with Growth and Healthy Term Infants, run by Perrigo Nutritionals at 6 sites in United States.
Trial summary
The purpose of this study is to show that a low lactose milk-based infant formula supports normal growth in healthy term infants. Read more about this study
- Who is it for?
- Ages Up to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Growth, Healthy Term Infants
- What is being tested?
- Low Lactose Infant Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 6 sitesUnited States
- Study dates
- Dec 2011to Mar 2013
- 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 Up to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy term infants
- birth weight 2500 - 4500 g
- singleton birth
- 37 - 42 weeks gestation
Who cannot join
- clinically significant abnormal findings (as determined by the investigator) on the physical examination or medical history
- receiving medications other than vitamins
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
PI-Coor Research
Burke, Virginia, 22015-1635
Research Across America
Dallas, Texas, 75234
ACC Pediatric Research
Haughton, Louisiana, 71037
Center for Pharmaceutical Research
Kansas City, Missouri, 64114
Accelovance Melbourne Site
Melbourne, Florida, 23935
Jean Brown Research
Murray, Utah, 84107
About this study
Official title: An Open Label Clinical Study to Evaluate Growth and Safety of a Low Lactose Milk-Based Infant Formula in Healthy Term Infants
The purpose of this study is to show that a low lactose milk-based infant formula supports normal growth in healthy term infants.
Read the detailed description
Infants will be fed a low lactose milk-based formula for 16 weeks. Growth and formula tolerability will be assessed.
- Conditions
- Growth, Healthy Term Infants
- Being tested
- Low Lactose Infant Formula
- Keywords
- healthy term infants, growth, infant formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Lactose Infant FormulaOther
Low Lactose Infant Formula
| Study group | Role | What they receive |
|---|---|---|
| Low Lactose Infant Formula | Other | Not described Receives: Other: Low Lactose Infant Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Measured: 16 weeks
Secondary outcomes (3)
Length gain
Measured: 16 weeks
Occipital Head Circumference
Measured: 16 weeks
Acceptability and Tolerability
Assessed by digestive tolerance; general health and well-being; adverse events; concomitant medications
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 posted22 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionMar 2013
- Study completionMar 2013
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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perrigo Nutritionals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cynthia M Barber, PhD, Study director, Perrigo Nutritionals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01497314
- Sponsor's protocol ID
- PRG-VA-12-001
- Status last verified
- May 2013
- First submitted
- 15 Dec 2011
- Last updated
- 15 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Clinical Study to Evaluate Growth and Safety of a Low Lactose Milk-Based Infant Formula in Healthy Term Infants
- ClinicalTrials.gov ID
- NCT01497314
- Acronym / sponsor ID
- PRG-VA-12-001
- Conditions
- Growth, Healthy Term Infants
- Keywords
- healthy term infants, growth, infant formula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Perrigo NutritionalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 22 Dec 2011 (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.
The purpose of this study is to show that a low lactose milk-based infant formula supports normal growth in healthy term infants.
Detailed description
Infants will be fed a low lactose milk-based formula for 16 weeks. Growth and formula tolerability will be assessed.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low Lactose Infant Formula | Other | Other: Low Lactose Infant Formula |
Who may qualify
- Ages
- Up to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- healthy term infants
- birth weight 2500 - 4500 g
- singleton birth
- 37 - 42 weeks gestation
Key exclusion criteria (2 listed)
- clinically significant abnormal findings (as determined by the investigator) on the physical examination or medical history
- receiving medications other than vitamins
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 |
|---|---|---|
| Low Lactose Infant FormulaLow Lactose Infant Formula | Other | Low Lactose Infant Formula |
Primary outcome
Weight
Time frame: 16 weeks
3 secondary outcomes
Length gain
Time frame: 16 weeks
Occipital Head Circumference
Time frame: 16 weeks
Acceptability and Tolerability
Time frame: 16 weeks
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 15 May 2013.
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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.
Cynthia M Barber, PhD study director
Perrigo Nutritionals
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Lactose Infant Formula in people with Growth and Healthy Term Infants, run by Perrigo Nutritionals at 6 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: finished, as of the sponsor's last update on 15 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Weight (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 15 May 2013.