NCT00153764

Brief Summary

The goal of the study is to evaluate the effectiveness of a new one-a-day Cooper complete vitamin supplement with or without a combined omega-3 fatty acid supplement on selected clinical risk factor measures. Participants taking the Cooper Complete one-a-day vitamin plus omega-3 fatty acid will have greater improvement in homocysteine, LDL cholesterol, and C-reactive protein than those taking the other supplements.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Sep 2004

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

August 2, 2012

Status Verified

August 1, 2012

Enrollment Period

1.5 years

First QC Date

September 7, 2005

Last Update Submit

August 1, 2012

Conditions

Healthy

Keywords

supplementomega-3 fatty acidHomocysteineLDL cholesterol

Outcome Measures

Primary Outcomes (2)

  • homocycsteine

  • LDL cholesterol oxidation rate

Secondary Outcomes (2)

  • fasting plasma glucose

  • C-reactive protein

Study Arms (1)

multivitamin

PLACEBO COMPARATOR

1 tablet morning and evening

Drug: Cooper Complete One-A-Day Vitamin Supplement

Interventions

Cooper Complete One-A-Day Vitamin SupplementDRUG
multivitamin

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age, maintain current diet and exercise regimen, not currently taking vitamins or agree to stop for 6 weeks

You may not qualify if:

  • BMI \<18.5 or \>34.9, recent blood donation, elevated blood pressure, cholesterol, or fasting blood glucose that requires medication, plans to move soon, or pregnant or plans to become pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Cooper Institute

Dallas, Texas, 75230, United States

Location

Study Officials

  • Conrad Earnest, PhD

    The Cooper Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

September 1, 2004

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

August 2, 2012

Record last verified: 2012-08

Locations

US(1)