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Vitamin C and Cardiovascular Risk

NCT00534014 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-03-12

No results posted yet for this study

Summary

Study Goal #1: Determine the optimal oral dose of vitamin C to reduce surrogate markers of atherosclerosis (blockages in blood vessels) following the consumption of an atherogenic high fat lunch in type 2 diabetic individuals.

Study Goal #2: After conducting the original study, we found that vitamin E was not effective in reducing the markers of oxidative stress, hypercoagulation, inflammation, and metabolic parameters in patients with type 2 diabetes.

To date, data from randomized trials have largely demonstrated no significant benefit of vitamin E supplementation on the prevention of primary and/or secondary cardiovascular disease as once thought. Therefore, we decided to amend our current protocol to add a Part B to study only the effects of vitamin C at the following doses: 500 mg, 1000 mg, and 2000 mg daily (and include a placebo arm, as well.

Conditions

Interventions

DIETARY_SUPPLEMENT

Vitamin C

Arm A = 0 mg Vitamin C, Arm B = 250 mg Vitamin C, Arm C = 500 mg Vitamin C, Arm D = 1000 mg Vitamin C

Sponsors & Collaborators

Principal Investigators

  • David S Schade, M.D. · University of New Mexico

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2007-03-31
Completion
2007-05-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00534014 on ClinicalTrials.gov