Effectiveness of a Vitamin Mineral Supplement

Condition(s) targeted: Healthy

Intervention: Cooper Complete One-A-Day Vitamin Supplement (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: The Cooper Institute

Official(s) and/or principal investigator(s):
Conrad Earnest, PhD, Principal Investigator, Affiliation: The Cooper Institute

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.

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

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

Primary outcome:

homocycsteine

LDL cholesterol oxidation rate

Secondary outcome:

fasting plasma glucose

C-reactive protein

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.

Minimum age: 30 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

The Cooper Institute, Dallas, Texas 75230, United States

Starting date: September 2004
Ending date: March 2006
Last updated: March 30, 2006