Overview

This trial is active, not recruiting.

Condition cardiovascular disease
Treatments vitamin c, vitamin e, placebo
Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator University of California, Berkeley
Start date April 2004
End date December 2008
Trial size 396 participants
Trial identifier NCT00079963, 62378DK

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Vitamin C
vitamin c
1000 mg/day
(Experimental)
Vitamin E
vitamin e
800 IU/day
(Placebo Comparator)
Placebo
placebo

Primary Outcomes

Measure
Change in high-sensitivity C-reactive protein (hsCRP)
time frame: 8-week intervention

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Gender, Obesity, C-Reactive Protein, and Oxidative Stress
Principal investigator Gladys Block, Ph.D.
Description Participants will be given 1000 mg vitamin C or 800 IU vitamin E daily for 60 days.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).