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Effectiveness of a Vitamin Mineral Supplement

NCT ID: NCT00153764

Last Updated: 2012-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2006-03-31

Brief Summary

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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.

Detailed Description

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Participants will be randomized to 1 of 3 groups: vitamin with omega-3, vitamin w/o omega-3, or omega-3 alone. They will take the vitamin 12 weeks, after which time they will return for all laboratory tests. Persons who are currently taking a supplement must undergo a 2-week washout period before beginning the study. 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.

Conditions

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Healthy

Keywords

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supplement omega-3 fatty acid Homocysteine LDL cholesterol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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multivitamin

1 tablet morning and evening

Group Type PLACEBO_COMPARATOR

Cooper Complete One-A-Day Vitamin Supplement

Intervention Type DRUG

Interventions

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Cooper Complete One-A-Day Vitamin Supplement

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 30-70 years of age, maintain current diet and exercise regimen, not currently taking vitamins or agree to stop for 6 weeks

Exclusion Criteria

* 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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cooper Clinic

UNKNOWN

Sponsor Role collaborator

The Cooper Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Conrad Earnest, PhD

Role: PRINCIPAL_INVESTIGATOR

The Cooper Institute

Locations

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The Cooper Institute

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CI0039

Identifier Type: -

Identifier Source: org_study_id