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

September 7, 2005
August 1, 2012
September 2004
March 2006   (final data collection date for primary outcome measure)
  • homocycsteine
  • LDL cholesterol oxidation rate
Same as current
Complete list of historical versions of study NCT00153764 on ClinicalTrials.gov Archive Site
  • fasting plasma glucose
  • C-reactive protein
Same as current
Not Provided
Not Provided
 
Effectiveness of a Vitamin Mineral Supplement
Effectiveness of a One-a-Day Cooper Complete Vitamin / Mineral Supplement With or Without Omega-3 Fatty Acid Ingestion

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Healthy
Drug: Cooper Complete One-A-Day Vitamin Supplement
Placebo Comparator: multivitamin
1 tablet morning and evening
Intervention: Drug: Cooper Complete One-A-Day Vitamin Supplement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
March 2006
March 2006   (final data collection date for primary outcome measure)

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
Both
30 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00153764
CI0039
No
The Cooper Institute
The Cooper Institute
Cooper Clinic
Principal Investigator: Conrad Earnest, PhD The Cooper Institute
The Cooper Institute
August 2012

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