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Gender, Obesity, C-Reactive Protein, and Oxidative Stress

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00079963
First received: March 18, 2004
Last updated: January 14, 2010
Last verified: January 2010
History of Changes
  Purpose

This randomized placebo-controlled trial will test whether supplementing with vitamins C and E can lower markers of inflammation and oxidative stress in healthy adults. We will examine whether one antioxidant vitamin is more effective than another, and whether gender or body fat influence the treatment effects. We will also determine whether gender, body fat, or menopausal status are associated with baseline concentrations of inflammation and oxidative stress markers.


Condition Intervention
Cardiovascular Disease
 Dietary Supplement: Vitamin C
Dietary Supplement: Vitamin E
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Change in high-sensitivity C-reactive protein (hsCRP) [ Time Frame: 8-week intervention ]

Secondary Outcome Measures:
  • Change in blood pressure [ Time Frame: 8-week intervention ]
  • Change in self-reported stress and psychosocial factors [ Time Frame: 8-week intervention ]
  • Change in oxidative stress biomarkers (F2-Isoprostanes, malondialdehyde) [ Time Frame: 8-week intervention ]
  • Association of gender, body fat, menopausal status with baseline concentrations of inflammation and oxidative stress biomarkers. [ Time Frame: Baseline ]

Enrollment: 396
Study Start Date: April 2004
Arms Assigned Interventions
Experimental: X Dietary Supplement: Vitamin C
1000 mg/day
Experimental: Y Dietary Supplement: Vitamin E
800 IU/day
Placebo Comparator: Z Dietary Supplement: Placebo

Detailed Description:

Participants will be given 1000 mg vitamin C or 800 IU vitamin E daily for 60 days.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Nonsmoker and not passively exposed
  • Males and females 18 year and older
  • Able to take vitamin supplements
  • Able to take acetominophen instead of aspirin or NSAIDs during the study

Exclusion criteria:

  • Pregnancy or lactation
  • History of ever smoking or passive smoke exposure in the last year
  • Active liver disease; history of HIV/AIDS, diabetes, kidney stones, hemochromatosis, or autoimmune diseases; heart disease, stroke, or cancer in the last 5 years
  • User of prescribed anti-inflammatory or lipid-lowering medications, oral contraceptives, hormone replacement therapy, or blood-thinning drugs
  • User of iron supplements or vitamin E at 600 IU per day or more
  • Consumption of more than 2 alcoholic beverages per day
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00079963

Locations
United States, California
University of California, Berkeley School of Public Health
Berkeley, California, United States, 94720-7360
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Gladys Block, Ph.D. University of California at Berkeley
  More Information

No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00079963     History of Changes
Other Study ID Numbers: 62378DK
Study First Received: March 18, 2004
Last Updated: January 14, 2010
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Ascorbic Acid
Vitamin E
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