Cognitive DevelopmentNCT00753818
Developmental Effects of Infant Formula Supplemented With LCPUFA
A study testing DHA and ARA in people with Cognitive Development and Growth, run by Mead Johnson Nutrition at 2 sites in United States.
Trial summary
The purpose of this study is to compare the effects on visual development, growth, cognitive development, tolerance, and blood chemistry parameters in term infants fed one of four study formulas containing various levels of DHA and ARA. Read more about this study
- Who is it for?
- Ages 1 day to 5 daysHealthy volunteers can take part
- Conditions the study is for
- Cognitive Development, Growth
- What is being tested?
- DHA and ARA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Start not givento not given
- 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 5 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy, term, formula fed infants from 1-5 days of age
Who cannot join
- history of disease that effects normal growth and development
- breast fed, or formula intolerance
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The University of Texas Southwestern Medical Center at Dallas
Dallas, Texas
The University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
The purpose of this study is to compare the effects on visual development, growth, cognitive development, tolerance, and blood chemistry parameters in term infants fed one of four study formulas containing various levels of DHA and ARA.
- Conditions
- Cognitive Development, Growth
- Being tested
- DHA and ARA, Control
- Keywords
- infant formula, visual development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHA and ARAOther
various levels of DHA and ARA
ControlOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Other: DHA and ARA |
| 2 | Experimental | Not described Receives: Other: DHA and ARA |
| 3 | Experimental | Not described Receives: Other: DHA and ARA |
| 4 | Other | Control Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual development
Secondary outcomes (1)
Cognitive development
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cognitive 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
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00753818
- Sponsor's protocol ID
- 3370-2(-4)
- Status last verified
- Sep 2008
- First submitted
- 16 Sep 2008
- Last updated
- 17 Sep 2008
- Results posted
- No
Publications
Liao K, McCandliss BD, Carlson SE, Colombo J, Shaddy DJ, Kerling EH, Lepping RJ, Sittiprapaporn W, Cheatham CL, Gustafson KM. Event-related potential differences in children supplemented with long-chain polyunsaturated fatty acids during infancy. Dev Sci. 2017 Sep;20(5):10.1111/desc.12455. doi: 10.1111/desc.12455. Epub 2016 Oct 16.
PubMed 27747986Drover JR, Felius J, Hoffman DR, Castaneda YS, Garfield S, Wheaton DH, Birch EE. A randomized trial of DHA intake during infancy: school readiness and receptive vocabulary at 2-3.5 years of age. Early Hum Dev. 2012 Nov;88(11):885-91. doi: 10.1016/j.earlhumdev.2012.07.007. Epub 2012 Jul 25.
PubMed 22835597Birch EE, Carlson SE, Hoffman DR, Fitzgerald-Gustafson KM, Fu VL, Drover JR, Castaneda YS, Minns L, Wheaton DK, Mundy D, Marunycz J, Diersen-Schade DA. The DIAMOND (DHA Intake And Measurement Of Neural Development) Study: a double-masked, randomized controlled clinical trial of the maturation of infant visual acuity as a function of the dietary level of docosahexaenoic acid. Am J Clin Nutr. 2010 Apr;91(4):848-59. doi: 10.3945/ajcn.2009.28557. Epub 2010 Feb 3.
PubMed 20130095
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developmental Effects of Infant Formula Supplemented With LCPUFA
- ClinicalTrials.gov ID
- NCT00753818
- Acronym / sponsor ID
- 3370-2(-4)
- Conditions
- Cognitive Development, Growth
- Keywords
- infant formula, visual development
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- First posted
- 17 Sep 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.
The purpose of this study is to compare the effects on visual development, growth, cognitive development, tolerance, and blood chemistry parameters in term infants fed one of four study formulas containing various levels of DHA and ARA.
Study design
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: DHA and ARA |
| 2 | Experimental | Other: DHA and ARA |
| 3 | Experimental | Other: DHA and ARA |
| 4 | Other | Other: ControlControl |
Who may qualify
- Ages
- 1 day to 5 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- healthy, term, formula fed infants from 1-5 days of age
Key exclusion criteria (2 listed)
- history of disease that effects normal growth and development
- breast fed, or formula intolerance
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 |
|---|---|---|
| DHA and ARAvarious levels of DHA and ARA | Other | 1, 2, 3 |
| Control | Other | 4 |
Primary outcome
visual development
1 secondary outcome
Cognitive development
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 17 Sep 2008.
- Derived from this study: PubMed 27747986Liao K, McCandliss BD, Carlson SE, Colombo J, Shaddy DJ, Kerling EH, Lepping RJ, Sittiprapaporn W, Cheatham CL, Gustafson KM. Event-related potential differences in children supplemented with long-chain polyunsaturated fatty acids during infancy. Dev Sci. 2017 Sep;20(5):10.1111/desc.12455. doi: 10.1111/desc.12455. Epub 2016 Oct 16.
- Derived from this study: PubMed 22835597Drover JR, Felius J, Hoffman DR, Castaneda YS, Garfield S, Wheaton DH, Birch EE. A randomized trial of DHA intake during infancy: school readiness and receptive vocabulary at 2-3.5 years of age. Early Hum Dev. 2012 Nov;88(11):885-91. doi: 10.1016/j.earlhumdev.2012.07.007. Epub 2012 Jul 25.
- Derived from this study: PubMed 20130095Birch EE, Carlson SE, Hoffman DR, Fitzgerald-Gustafson KM, Fu VL, Drover JR, Castaneda YS, Minns L, Wheaton DK, Mundy D, Marunycz J, Diersen-Schade DA. The DIAMOND (DHA Intake And Measurement Of Neural Development) Study: a double-masked, randomized controlled clinical trial of the maturation of infant visual acuity as a function of the dietary level of docosahexaenoic acid. Am J Clin Nutr. 2010 Apr;91(4):848-59. doi: 10.3945/ajcn.2009.28557. Epub 2010 Feb 3.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DHA and ARA in people with Cognitive Development and Growth, run by Mead Johnson Nutrition at 2 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 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 17 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
visual development. 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 NCT00753818, which also lists 3 linked publications.
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 17 Sep 2008.