AtherosclerosisNCT00005412
Dietary Antioxidants and Atherosclerosis
An observational study of Atherosclerosis and Cardiovascular Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To examine the role of dietary antioxidants in the etiology of atherosclerosis in both sexes and in whites and Blacks. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Atherosclerosis, Cardiovascular Diseases, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1992to Jun 1995
- Phase
- Observational
- 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To examine the role of dietary antioxidants in the etiology of atherosclerosis in both sexes and in whites and Blacks.
Read the detailed description
BACKGROUND:
Atherosclerosis is this nation's leading cause of death for males and females, and Blacks and whites. There is mounting evidence that the oxidation of blood low density lipoproteins (LDL) plays an important role in the pathogenesis of this disease. LDL oxidation can be prevented by several dietary antioxidants, in particular, vitamin C, vitamin E, and beta-carotene. There is preliminary evidence that dietary antioxidants may slow the natural history of atherosclerosis in humans. Until now studies in this area have included predominantly white males with symptomatic disease.
DESIGN NARRATIVE:
The case-control study used data collected in ARIC to test the hypothesis that individuals in the lowest quintile of vitamin C, vitamin E and carotenoid consumption were at higher risk of asymptomatic atherosclerosis than those consuming greater amounts. Antioxidant intake was assessed by a validated food frequency questionnaire and a diet supplement survey. Cases were those with asymptomatic carotid artery atherosclerosis as determined by B-mode ultrasonography. Controls were those without evidence of carotid artery atherosclerosis. Secondary analyses determined which sex-race subgroups were at particular risk due to low antioxidant consumption.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Medical subject headings
- Atherosclerosis, Cardiovascular Diseases, Heart Diseases, Carotid Stenosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startJul 1992
- Study completionJun 1995
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 AtherosclerosisStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)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
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005412
- Sponsor's protocol ID
- 4330
- Other IDs
- R03HL047408
- Status last verified
- Jun 2000
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
Kritchevsky SB, Shimakawa T, Tell GS, Dennis B, Carpenter M, Eckfeldt JH, Peacher-Ryan H, Heiss G. Dietary antioxidants and carotid artery wall thickness. The ARIC Study. Atherosclerosis Risk in Communities Study. Circulation. 1995 Oct 15;92(8):2142-50. doi: 10.1161/01.cir.92.8.2142.
PubMed 7554194Kritchevsky SB, Tell GS, Shimakawa T, Dennis B, Li R, Kohlmeier L, Steere E, Heiss G. Provitamin A carotenoid intake and carotid artery plaques: the Atherosclerosis Risk in Communities Study. Am J Clin Nutr. 1998 Sep;68(3):726-33. doi: 10.1093/ajcn/68.3.726.
PubMed 9734754
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Antioxidants and Atherosclerosis
- ClinicalTrials.gov ID
- NCT00005412
- Acronym / sponsor ID
- 4330
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jul 1992
- Study completion
- Jun 1995 (actual)
- First posted
- 26 May 2000 (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.
To examine the role of dietary antioxidants in the etiology of atherosclerosis in both sexes and in whites and Blacks.
Detailed description
BACKGROUND:
Atherosclerosis is this nation's leading cause of death for males and females, and Blacks and whites. There is mounting evidence that the oxidation of blood low density lipoproteins (LDL) plays an important role in the pathogenesis of this disease. LDL oxidation can be prevented by several dietary antioxidants, in particular, vitamin C, vitamin E, and beta-carotene. There is preliminary evidence that dietary antioxidants may slow the natural history of atherosclerosis in humans. Until now studies in this area have included predominantly white males with symptomatic disease.
DESIGN NARRATIVE:
The case-control study used data collected in ARIC to test the hypothesis that individuals in the lowest quintile of vitamin C, vitamin E and carotenoid consumption were at higher risk of asymptomatic atherosclerosis than those consuming greater amounts. Antioxidant intake was assessed by a validated food frequency questionnaire and a diet supplement survey. Cases were those with asymptomatic carotid artery atherosclerosis as determined by B-mode ultrasonography. Controls were those without evidence of carotid artery atherosclerosis. Secondary analyses determined which sex-race subgroups were at particular risk due to low antioxidant consumption.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 13 May 2016.
- Background: PubMed 7554194Kritchevsky SB, Shimakawa T, Tell GS, Dennis B, Carpenter M, Eckfeldt JH, Peacher-Ryan H, Heiss G. Dietary antioxidants and carotid artery wall thickness. The ARIC Study. Atherosclerosis Risk in Communities Study. Circulation. 1995 Oct 15;92(8):2142-50. doi: 10.1161/01.cir.92.8.2142.
- Background: PubMed 9734754Kritchevsky SB, Tell GS, Shimakawa T, Dennis B, Li R, Kohlmeier L, Steere E, Heiss G. Provitamin A carotenoid intake and carotid artery plaques: the Atherosclerosis Risk in Communities Study. Am J Clin Nutr. 1998 Sep;68(3):726-33. doi: 10.1093/ajcn/68.3.726.
Related trials for Atherosclerosis
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis and Cardiovascular Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005412, 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 13 May 2016.