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OpenTrials
Completed

NCT Number: NCT00079963

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.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Berkeley School of Public Health

Berkeley, California, 94720-7360, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin C

Dietary Supplement

1000 mg/day

Vitamin E

Dietary Supplement

800 IU/day

Placebo

Dietary Supplement

Primary outcomes

  1. Change in high-sensitivity C-reactive protein (hsCRP)

    Time frame: 8-week intervention

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Nih

Collaborators

  • Kaiser Permanente
  • University of California, Berkeley

Registry information

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Mar 22, 2004
Registry last updated
Sep 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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