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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00079963
Recruitment Status : Completed
First Posted : March 22, 2004
Last Update Posted : September 27, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Cardiovascular Disease Dietary Supplement: Vitamin C Dietary Supplement: Vitamin E Dietary Supplement: Placebo

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 396 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Gender, Obesity, C-Reactive Protein, and Oxidative Stress
Study Start Date : April 2004
Primary Completion Date : March 24, 2008
Study Completion Date : March 24, 2008
Arms and Interventions

Arm Intervention/treatment
Experimental: X
Vitamin C
Dietary Supplement: Vitamin C
1000 mg/day
Experimental: Y
Vitamin E
Dietary Supplement: Vitamin E
800 IU/day
Placebo Comparator: Z
Placebo
Dietary Supplement: Placebo


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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)
University of California, Berkeley
Kaiser Permanente
Investigators
Principal Investigator: Gladys Block, Ph.D. University of California at Berkeley
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00079963     History of Changes
Other Study ID Numbers: 62378DK
R01DK062378 ( U.S. NIH Grant/Contract )
First Posted: March 22, 2004    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Cardiovascular Diseases
Vitamins
Ascorbic Acid
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents