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Effectiveness of a Vitamin Mineral Supplement (Omega-3)

This study has been completed.
Sponsor:
Collaborator:
Cooper Clinic
Information provided by (Responsible Party):
The Cooper Institute
ClinicalTrials.gov Identifier:
NCT00153764
First received: September 7, 2005
Last updated: August 1, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention Phase
Healthy
 Drug: Cooper Complete One-A-Day Vitamin Supplement
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Cooper Institute:

Primary Outcome Measures:
  • homocycsteine
  • LDL cholesterol oxidation rate

Secondary Outcome Measures:
  • fasting plasma glucose
  • C-reactive protein

Enrollment: 75
Study Start Date: September 2004
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: multivitamin
1 tablet morning and evening
 Drug: Cooper Complete One-A-Day Vitamin Supplement

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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: The Cooper Institute
ClinicalTrials.gov Identifier: NCT00153764     History of Changes
Other Study ID Numbers: CI0039
Study First Received: September 7, 2005
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013