NCT00753818

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2008

Completed
Last Updated

September 17, 2008

Status Verified

September 1, 2008

First QC Date

September 16, 2008

Last Update Submit

September 16, 2008

Conditions

Cognitive DevelopmentGrowth

Keywords

infant formulavisual development

Outcome Measures

Primary Outcomes (1)

  • visual development

Secondary Outcomes (1)

  • Cognitive development

Study Arms (4)

1

EXPERIMENTAL
Other: DHA and ARA

2

EXPERIMENTAL
Other: DHA and ARA

3

EXPERIMENTAL
Other: DHA and ARA

4

OTHER

Control

Other: Control

Interventions

DHA and ARAOTHER

various levels of DHA and ARA

123
ControlOTHER
4

Eligibility Criteria

Age1 Day - 5 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • healthy, term, formula fed infants from 1-5 days of age

You may not qualify if:

  • history of disease that effects normal growth and development
  • breast fed, or formula intolerance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

The University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

Location

Related Publications (3)

  • 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.

    PMID: 27747986DERIVED

  • Drover 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.

    PMID: 22835597DERIVED

  • Birch 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.

    PMID: 20130095DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 16, 2008

First Posted

September 17, 2008

Last Updated

September 17, 2008

Record last verified: 2008-09

Locations

US(2)