GrowthNCT02144402
Growth of Healthy Term Infants Fed Formula Containing DHA-B
A study testing infant formula with DHASCO and infant formula with DHASCO-B in people with Growth and Tolerance, run by dsm-firmenich Switzerland AG at 10 sites in United States.
Trial summary
The primary objective is to determine if the weight gain of healthy term infants fed a commercially available term infant formula supplemented with DHASCO® is similar to that of infants fed the same formula supplemented with a new product, DHASCO®-B. Read more about this study
- Who is it for?
- Ages 1 day to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Growth, Tolerance, Infant Development
- What is being tested?
- infant formula with DHASCO and infant formula with DHASCO-B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 10 sitesUnited States
- Study dates
- May 2014to Jul 2015
- 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
- full term infant (gestational age 37-42 weeks)
- birth weight > or equal to 2500 g
- singleton infant < or equal to 14 days of age in good health
- parent must be >21 years of age
- parental consent
Who cannot join
- congenital malformation or genetic disorder
- metabolic anomalies
- maternal infectious diseases, alcoholism, substance abuse
- mothers with gestational diabetes
- participation in another clinical study
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Ohio Pediatric Research
Dayton, Ohio, 45414
Claude Ashley, MD
Dothan, Alabama, 36305
Stephen Kasparian
Fall River, Massachusetts, 02720
JBRKIDS
Jonesboro, Arkansas, 72401
MCHRI
Lincoln, Nebraska, 68504
Pedia Research
Newburgh, Indiana, 47630
Norwich Pediatric
Norwich, Connecticut, 06360
Score Physician Alliance
St. Petersburg, Florida, 33710
Atlantic Clinical Research
Wellington, Florida, 33414
Heartland Research
Wichita, Kansas, 67205
About this study
The primary objective is to determine if the weight gain of healthy term infants fed a commercially available term infant formula supplemented with DHASCO® is similar to that of infants fed the same formula supplemented with a new product, DHASCO®-B.
- Conditions
- Growth, Tolerance, Infant Development
- Being tested
- infant formula with DHASCO, infant formula with DHASCO-B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infant formula with DHASCOOther
infant formula with DHASCO-BOther
| Study group | Role | What they receive |
|---|---|---|
| infant formula with DHASCO | Active comparator | standard infant formula with docosahexaenoic acid (DHA) Receives: Other: infant formula with DHASCO |
| infant formula with DHASCO-B | Experimental | standard infant formula with DHA-B Receives: Other: infant formula with DHASCO-B |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight gain (gm/day)
gm/day -calculated from the weight measured at enrollment subtracted from the weight measured at DOL 120 visit, divided by the number of days between the actual visits.
Measured: through day of life 120
Secondary outcomes (4)
length (cm)
Length in cm
Measured: through day of life 120
head circumference (cm)
head circumference (cm)
Measured: through day of life 120
fatty acid levels (wgt %)
red blood cell (RBC) levels of omega-3 and omega-6 fatty acids (wgt %) in a sample subset
Measured: at day of life 120
Formula intake and tolerance
assessed by analyzing three-day dietary intake and tolerance forms
Measured: Day of life 30 and 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study startMay 2014
- Primary completionJul 2015
- Study completionJul 2015
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- dsm-firmenich Switzerland AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Accelovance
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02144402
- Sponsor's protocol ID
- 2013-1069
- Status last verified
- Aug 2015
- First submitted
- 16 May 2014
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth of Healthy Term Infants Fed Formula Containing DHA-B
- ClinicalTrials.gov ID
- NCT02144402
- Acronym / sponsor ID
- 2013-1069
- Conditions
- Growth, Tolerance, Infant Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- dsm-firmenich Switzerland AGIndustry (pharma, biotech, devices)
- Collaborators
- Accelovance
- Study start
- May 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 22 May 2014 (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 primary objective is to determine if the weight gain of healthy term infants fed a commercially available term infant formula supplemented with DHASCO® is similar to that of infants fed the same formula supplemented with a new product, DHASCO®-B.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| infant formula with DHASCO | Active comparator | Other: infant formula with DHASCOstandard infant formula with docosahexaenoic acid (DHA) |
| infant formula with DHASCO-B | Experimental | Other: infant formula with DHASCO-Bstandard infant formula with DHA-B |
Who may qualify
- Ages
- 1 day to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- full term infant (gestational age 37-42 weeks)
- birth weight > or equal to 2500 g
- singleton infant < or equal to 14 days of age in good health
- parent must be >21 years of age
- parental consent
Key exclusion criteria (5 listed)
- congenital malformation or genetic disorder
- metabolic anomalies
- maternal infectious diseases, alcoholism, substance abuse
- mothers with gestational diabetes
- participation in another clinical study
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 formula with DHASCO | Other | infant formula with DHASCO |
| infant formula with DHASCO-B | Other | infant formula with DHASCO-B |
Primary outcome
weight gain (gm/day)
Time frame: through day of life 120
gm/day -calculated from the weight measured at enrollment subtracted from the weight measured at DOL 120 visit, divided by the number of days between the actual visits.
4 secondary outcomes
length (cm)
Time frame: through day of life 120
head circumference (cm)
Time frame: through day of life 120
fatty acid levels (wgt %)
Time frame: at day of life 120
Formula intake and tolerance
Time frame: Day of life 30 and 120
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 4 Aug 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 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 with DHASCO and infant formula with DHASCO-B in people with Growth and Tolerance, run by dsm-firmenich Switzerland AG at 10 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 5 inclusion and 5 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 4 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 gain (gm/day) (time frame: through day of life 120). 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 4 Aug 2015.