Cardiovascular DiseaseNCT00079963
Gender, Obesity, C-Reactive Protein, and Oxidative Stress
A study testing Vitamin C and Vitamin E in people with Cardiovascular Disease, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Vitamin C and Vitamin E
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 396 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to 24 Mar 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Berkeley School of Public Health
Berkeley, California, 94720-7360
About this study
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.
Read the detailed description
Participants will be given 1000 mg vitamin C or 800 IU vitamin E daily for 60 days.
- Conditions
- Cardiovascular Disease
- Being tested
- Vitamin C, Vitamin E, Placebo
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDietary supplement
1000 mg/day
Vitamin EDietary supplement
800 IU/day
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| X | Experimental | Vitamin C Receives: Dietary Supplement: Vitamin C |
| Y | Experimental | Vitamin E Receives: Dietary Supplement: Vitamin E |
| Z | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in high-sensitivity C-reactive protein (hsCRP)
Measured: 8-week intervention
Secondary outcomes (4)
Change in blood pressure
Measured: 8-week intervention
Change in self-reported stress and psychosocial factors
Measured: 8-week intervention
Change in oxidative stress biomarkers (F2-Isoprostanes, malondialdehyde)
Measured: 8-week intervention
Association of gender, body fat, menopausal status with baseline concentrations of inflammation and oxidative stress biomarkers.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2004 (estimated)
- Study startApr 2004
- Primary completion24 Mar 2008
- Study completion24 Mar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 396 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of California, Berkeley, Kaiser Permanente
- Responsible party
- Sponsor
- Investigators
- Gladys Block, Ph.D., Principal investigator, University of California at Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00079963
- Sponsor's protocol ID
- 62378DK
- Other IDs
- R01DK062378
- Status last verified
- Sep 2017
- First submitted
- 18 Mar 2004
- Last updated
- 27 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18455517Block 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.
PubMed 21813807
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender, Obesity, C-Reactive Protein, and Oxidative Stress
- ClinicalTrials.gov ID
- NCT00079963
- Acronym / sponsor ID
- 62378DK
- Conditions
- Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 396 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Collaborators
- University of California, Berkeley, Kaiser Permanente
- Study start
- Apr 2004
- Primary completion
- 24 Mar 2008 (actual)
- Study completion
- 24 Mar 2008 (actual)
- First posted
- 22 Mar 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants will be given 1000 mg vitamin C or 800 IU vitamin E daily for 60 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| X | Experimental | Dietary Supplement: Vitamin CVitamin C |
| Y | Experimental | Dietary Supplement: Vitamin EVitamin E |
| Z | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin C1000 mg/day | Dietary supplement | X |
| Vitamin E800 IU/day | Dietary supplement | Y |
| Placebo | Dietary supplement | Z |
Primary outcome
Change in high-sensitivity C-reactive protein (hsCRP)
Time frame: 8-week intervention
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2017.
- Results publication: PubMed 18455517Block 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.
- Derived from this study: PubMed 21813807Block 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gladys Block, Ph.D. principal investigator
University of California at Berkeley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin C and Vitamin E in people with Cardiovascular Disease, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in high-sensitivity C-reactive protein (hsCRP) (time frame: 8-week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00079963, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2017.