Effectiveness of a Vitamin Mineral Supplement

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Cooper Complete One-A-Day Vitamin Supplement

• Registration Number: NCT00153764
• Lead Sponsor: The Cooper Institute

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 Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-12
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-01
• Last Update Posted: 2012-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
multivitamin	Cooper Complete One-A-Day Vitamin Supplement	1 tablet morning and evening

Primary Outcome Measures

Name	Time	Method
homocycsteine
LDL cholesterol oxidation rate

Secondary Outcome Measures

Name	Time	Method
fasting plasma glucose
C-reactive protein

Trial Locations

Locations (1)

The Cooper Institute; 🇺🇸 Dallas, Texas, United States