NCT00079963

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
396

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 22, 2004

Completed
10 days until next milestone

Study Start

First participant enrolled

April 1, 2004

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2008

Completed
Last Updated

September 27, 2017

Status Verified

September 1, 2017

Enrollment Period

4 years

First QC Date

March 18, 2004

Last Update Submit

September 25, 2017

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • Change in high-sensitivity C-reactive protein (hsCRP)

    8-week intervention

Secondary Outcomes (4)

  • Change in blood pressure

    8-week intervention

  • Change in self-reported stress and psychosocial factors

    8-week intervention

  • Change in oxidative stress biomarkers (F2-Isoprostanes, malondialdehyde)

    8-week intervention

  • Association of gender, body fat, menopausal status with baseline concentrations of inflammation and oxidative stress biomarkers.

    Baseline

Study Arms (3)

X

EXPERIMENTAL

Vitamin C

Dietary Supplement: Vitamin C

Y

EXPERIMENTAL

Vitamin E

Dietary Supplement: Vitamin E

Z

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

Vitamin CDIETARY_SUPPLEMENT

1000 mg/day

X
Vitamin EDIETARY_SUPPLEMENT

800 IU/day

Y
PlaceboDIETARY_SUPPLEMENT
Z

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Berkeley School of Public Health

Berkeley, California, 94720-7360, United States

Location

Related Publications (2)

  • 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;45(4):377-84. doi: 10.1016/j.freeradbiomed.2008.04.005. Epub 2008 Apr 16.

    PMID: 18455517RESULT

  • Block G, Shaikh N, Jensen CD, Volberg V, Holland N. Serum vitamin C and other biomarkers differ by genotype of phase 2 enzyme genes GSTM1 and GSTT1. Am J Clin Nutr. 2011 Sep;94(3):929-37. doi: 10.3945/ajcn.111.011460. Epub 2011 Aug 3.

    PMID: 21813807DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Ascorbic AcidVitamin E

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydratesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Gladys Block, Ph.D.

    University of California at Berkeley

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2004

First Posted

March 22, 2004

Study Start

April 1, 2004

Primary Completion

March 24, 2008

Study Completion

March 24, 2008

Last Updated

September 27, 2017

Record last verified: 2017-09

Locations

US(1)