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Vitamin C and Cardiovascular Risk

This study has been completed.
Sponsor:
Collaborator:
American Diabetes Association
Information provided by:
University of New Mexico
ClinicalTrials.gov Identifier:
NCT00534014
First received: September 20, 2007
Last updated: March 31, 2008
Last verified: March 2008
History of Changes
  Purpose

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.


Condition Intervention
Atherosclerosis
Type 2 Diabetes
 Dietary Supplement: Vitamin C

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Vitamin C Therapy in Type 2 Diabetes and Cardiovascular Risk

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • To determine the optimal oral dose of vitamin C and E to reduce surrogate markers of atherosclerosis (blockages in blood vessels) following the consumption of an atherogenic high fat lunch in type 2 diabetic individuals. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To study the effects of vitamin C on fibrinogen, insulin, glucose, PAI-1, adiponectin, free MDA, Oxy LDL,CRP, cholesterol, and FFA. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: January 2006
Study Completion Date: May 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A
0 mg of Vitamin C
 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
Active Comparator: B
250 mg Vitamin C
 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
Active Comparator: C
500 mg Vitamin C
 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
Active Comparator: D
1000 mg Vitamin C
 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

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  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetic for at lease 6 months
  • Body mass index less than 40kg/m2
  • Normal EEG's
  • Normal test results from screening visit.

Exclusion Criteria:

  • Known vascular disease
  • Uncontrolled hypertension (>140/90 mmHg) or marked hyperlipidemia (serum low denisity lipoprotein >4.1 mmol/L or serum triglycerides > 7.8 mmol/L)
  • Pregnancy
  • Cigarette smoking
  • Currently taking coumadin
  • Recent use of antioxidant supplements or asprin.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00534014

Locations
United States, New Mexico
University of New Mexico , Clinical Translational Science Center
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
American Diabetes Association
Investigators
Principal Investigator: David S Schade, M.D. University of New Mexico
  More Information

No publications provided

Responsible Party: David S. Schade, University of New Mexico
ClinicalTrials.gov Identifier: NCT00534014     History of Changes
Other Study ID Numbers: 04-319B
Study First Received: September 20, 2007
Last Updated: March 31, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Atherosclerosis
Diabetes Mellitus
Diabetes Mellitus, Type 2
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Ascorbic Acid
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on June 17, 2013