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

• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00079963
• Collaborator: University of California, Berkeley (Other), Kaiser Permanente (Other)
• Enrollment: 396
• Location: 1
• Arms: 3
• Duration (Months): 47.7
• Patients Per Site Per Month: 8.3

Study Details

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	Phase
Cardiovascular Disease	Dietary Supplement: Vitamin C; Dietary Supplement: Vitamin E; Dietary Supplement: Placebo	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• 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: Apr 1, 2004
• Actual Primary Completion Date: Mar 24, 2008
• Actual Study Completion Date: Mar 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) [8-week intervention]

Secondary Outcome Measures

1. Change in blood pressure [8-week intervention]

2. Change in self-reported stress and psychosocial factors [8-week intervention]

3. Change in oxidative stress biomarkers (F2-Isoprostanes, malondialdehyde) [8-week intervention]

4. Association of gender, body fat, menopausal status with baseline concentrations of inflammation and oxidative stress biomarkers. [Baseline]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• ClinicalTrials.gov Identifier: NCT00079963
• Other Study ID Numbers: 62378DK; R01DK062378
• First Posted: Mar 22, 2004
• Last Update Posted: Sep 27, 2017
• Last Verified: Sep 1, 2017

• Additional relevant MeSH terms: Cardiovascular Diseases; Vitamins; Ascorbic Acid; Vitamin E

Study Results

No Results Posted as of Sep 27, 2017