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

National Institutes of Health (NIH)

Status: Completed

Conditions: Cardiovascular Disease

Treatments: Dietary Supplement: Vitamin E; Dietary Supplement: Vitamin C; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00079963

62378DK

R01DK062378 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 396 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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396 participants in 3 patient groups, including a placebo group

X

Experimental group

Description:

Vitamin C

Treatment:

Dietary Supplement: Vitamin C

Y

Experimental group

Description:

Vitamin E

Treatment:

Dietary Supplement: Vitamin E

Z

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Placebo