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Effectiveness of a Vitamin Mineral Supplement (Omega-3)

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ClinicalTrials.gov Identifier: NCT00153764
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : August 2, 2012
Sponsor:
Collaborator:
Cooper Clinic
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Cooper Complete One-A-Day Vitamin Supplement Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Effectiveness of a One-a-Day Cooper Complete Vitamin / Mineral Supplement With or Without Omega-3 Fatty Acid Ingestion
Study Start Date : September 2004
Primary Completion Date : March 2006
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: multivitamin
1 tablet morning and evening
Drug: Cooper Complete One-A-Day Vitamin Supplement



Primary Outcome Measures :
  1. homocycsteine
  2. LDL cholesterol oxidation rate

Secondary Outcome Measures :
  1. fasting plasma glucose
  2. C-reactive protein


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00153764


Locations
United States, Texas
The Cooper Institute
Dallas, Texas, United States, 75230
Sponsors and Collaborators
The Cooper Institute
Cooper Clinic
Investigators
Principal Investigator: Conrad Earnest, PhD The Cooper Institute

Responsible Party: The Cooper Institute
ClinicalTrials.gov Identifier: NCT00153764     History of Changes
Other Study ID Numbers: CI0039
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: August 2, 2012
Last Verified: August 2012

Keywords provided by The Cooper Institute:
supplement
omega-3 fatty acid
Homocysteine
LDL cholesterol

Additional relevant MeSH terms:
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs