Effectiveness of a Vitamin Mineral Supplement - Tabular View

Tracking Information

First Received Date ^ICMJE

September 7, 2005

Last Updated Date

March 30, 2006

Start Date ^ICMJE

September 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

homocycsteine
LDL cholesterol oxidation rate

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00153764 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

fasting plasma glucose
C-reactive protein

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Effectiveness of a Vitamin Mineral Supplement

Official Title ^ICMJE

Effectiveness of a One-a-Day Cooper Complete Vitamin / Mineral Supplement With or Without Omega-3 Fatty Acid Ingestion

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.

Detailed Description

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.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Randomized, Single Blind, Active Control, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: Cooper Complete One-A-Day Vitamin Supplement

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

March 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

30 Years to 70 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00153764

Responsible Party

Study ID Numbers ^ICMJE

CI0039

Study Sponsor ^ICMJE

The Cooper Institute

Collaborators ^ICMJE

Cooper Clinic

Investigators ^ICMJE

Principal Investigator:

Conrad Earnest, PhD

The Cooper Institute

Information Provided By

The Cooper Institute

Verification Date

March 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP