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Clinical Trial: Effectiveness of a Vitamin Mineral Supplement
This study is currently recruiting patients.
Verified by The Cooper Institute September 2005
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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 amega-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 homocycteine, LDL cholesterol, and C-reactive protein than those taking the other supplements.
| Condition | Intervention | Phase |
|---|---|---|
| Homocysteine LDL cholesterol | Drug: Cooper Complete One-A-Day Vitamin Supplement | Phase I |
MedlinePlus consumer health information
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
Further Study Details:
Primary Outcomes: homocycsteine; LDL cholesterol oxidation rate
Secondary Outcomes: fasting plasma glucose; C-reactive protein
Expected Total Enrollment: 75
Secondary Outcomes: fasting plasma glucose; C-reactive protein
Expected Total Enrollment: 75
Study start: September 2004; Expected completion: March 2006
Last follow-up: March 2006; Data entry closure: March 2006
Paticipants 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 homocycteine, LDL cholesterol, and C-reactive protein than those taking the other supplements.
Eligibility
Ages Eligible for Study: 30 Years - 70 Years, Genders Eligible for Study: Both
Accepts Healthy Volunteers
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:
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00153764
Jo Talley 972 341 3281 jtalley@cooperinst.org
Texas
The Cooper Institute, Dallas, Texas, 75230, United States; Recruiting
Jo Talley 972-341-3281 jtalley@cooperinst.org
Conrad Earnest, PhD, Principal Investigator
Conrad Earnest, PhD, Principal Investigator
Study chairs or principal investigators
Conrad Earnest, PhD, Principal Investigator, The Cooper Institute
More Information
Study ID Numbers: CI0039
Last Updated: September 9, 2005
Record first received: September 7, 2005
ClinicalTrials.gov Identifier: NCT00153764
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 9, 2005
Record first received: September 7, 2005
ClinicalTrials.gov Identifier: NCT00153764
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13
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