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

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00079963
• Other study ID #: 62378DK
• Secondary ID: R01DK062378
• Status: Completed
• Phase: N/A
• First received: March 18, 2004
• Last updated: September 25, 2017
• Start date: April 2004
• Est. completion date: March 24, 2008

Study information

• Verified date: September 2017
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 396
• Est. completion date: March 24, 2008
• Est. primary completion date: March 24, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Dietary Supplement:
• Vitamin C
1000 mg/day
• Vitamin E
800 IU/day
• Placebo

Locations

Country	Name	City	State
United States	University of California, Berkeley School of Public Health	Berkeley	California

Sponsors (3)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Kaiser Permanente, University of California, Berkeley

Country where clinical trial is conducted

United States, 

References & Publications (1)

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;4 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in high-sensitivity C-reactive protein (hsCRP)		8-week intervention
Secondary	Change in blood pressure		8-week intervention
Secondary	Change in self-reported stress and psychosocial factors		8-week intervention
Secondary	Change in oxidative stress biomarkers (F2-Isoprostanes, malondialdehyde)		8-week intervention
Secondary	Association of gender, body fat, menopausal status with baseline concentrations of inflammation and oxidative stress biomarkers.		Baseline