Effectiveness of a Vitamin Mineral Supplement - Full Text View

Sponsors and Collaborators:	The Cooper Institute Cooper Clinic
Information provided by:	The Cooper Institute
ClinicalTrials.gov Identifier:	NCT00153764

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 I

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Single Blind, Active Control, Single Group Assignment, Efficacy Study
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:

MedlinePlus related topics: Cholesterol Dietary Supplements Minerals

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

Estimated Enrollment:	75
Study Start Date:	September 2004
Estimated Study Completion Date:	March 2006

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

Study ID Numbers:	CI0039
Study First Received:	September 7, 2005
Last Updated:	March 30, 2006
ClinicalTrials.gov Identifier:	NCT00153764 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by The Cooper Institute:

supplement
omega-3 fatty acid
Homocysteine
LDL cholesterol

Study placed in the following topic categories:

Vitamins
Omega 3 Fatty Acid
Trace Elements
Micronutrients
Healthy

Additional relevant MeSH terms:

Growth Substances
Vitamins
Physiological Effects of Drugs
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009