| March 18, 2004 |
| October 19, 2007 |
| April 2004 |
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| Change in high-sensitivity C-reactive protein (hsCRP) [ Time Frame: 8-week intervention ] |
| Same as current |
| Complete list of historical versions of study NCT00079963 on ClinicalTrials.gov Archive Site |
- 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 ]
|
| Same as current |
| |
| Gender, Obesity, C-Reactive Protein, and Oxidative Stress |
| |
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. |
Participants will be given 1000 mg vitamin C or 800 IU vitamin E daily for 60 days. |
| |
| Interventional |
| Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
| Cardiovascular Disease |
- Dietary Supplement: Vitamin C
- Dietary Supplement: Vitamin E
- Dietary Supplement: Placebo
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| |
| Block G, Jensen CD, Morrow JD, Holland N, Norkus EP, Milne GL, Hudes M, Dalvi TB, Crawford PB, Fung EB, Schumacher L, Harmatz P. The effect of vitamins C and E on biomarkers of oxidative stress depends on baseline level. Free Radic Biol Med. 2008 Aug 15;45(4):377-84. Epub 2008 Apr 16. |
| |
| Active, not recruiting |
| 396 |
|
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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
|
| Both |
| 18 Years and older |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00079963 |
|
| 62378DK |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|
| Principal Investigator: |
Gladys Block, Ph.D. |
University of California at Berkeley |
|
|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| October 2007 |
