Myocardial InfarctionNCT03350568
Dietary Antioxidants and Chronic Diseases-The Swedish National March Cohort
An observational study of Myocardial Infarction and Diet, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Dietary antioxidants might protect from the development of chronic diseases by reducing levels of oxidative stress. The investigators therefore investigated the effect of dietary Non Enzymatic Antioxidant Capacity, which measures interactions between antioxidants in the whole diet, on the risk of 1) myocardial… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Diet, Osteoarthritis
- What is being tested?
- Total dietary NEAC assessed at baseline
- How many people
- 43,880 participants
- Where
- 1 siteSweden
- Study dates
- 1 Oct 1997to 31 Dec 2010
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Study 1: Study population (n=34,543) was between the age of 18-94 years and free from cancer (except non-melanoma skin cancer) or any cardiovascular disease before the beginning of follow up. Study 2: Study population (n=29,188) was between the age of 40-94 years and free from osteoarthritis, bone cancer or -metastases , joint injury, or any arthropathy disease other than.
Who may be able to join
None listed.
Who cannot join
- Incorrect national registration number
- Subjects who were <18 years
- Emigration before beginning of follow-up
- Death before beginning of follow-up
- Cancer diagnosis
- Any cardiovascular disease
Show all 15Show fewer
- Extreme energy intake
- Incorrect national registration number
- Subjects who were <40 years
- Emigration before beginning of follow-up
- Death before beginning of follow-up
- Osteoarthritis diagnosis
- Bone cancer- or metastases
- Joint injury or any arthropathy disease other than osteoarthritis
- Extreme energy intake
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study 1: Dietary Non Enzymatic Antioxidant Capacity and the Risk of Myocardial Infarction - The Swedish National March Cohort; Study 2: Dietary Total Antioxidant Capacity and Risk of Osteoarthritis in the Swedish National March Cohort
Dietary antioxidants might protect from the development of chronic diseases by reducing levels of oxidative stress. The investigators therefore investigated the effect of dietary Non Enzymatic Antioxidant Capacity, which measures interactions between antioxidants in the whole diet, on the risk of 1) myocardial infarction and 2) osteoarthritis.
Read the detailed description
Aim: Among an initial sample of 43,880 men and women who participated in the Swedish National March Cohort in 1997 the investigators aimed to investigate the effect of dietary Non Enzymatic Antioxidant Capacity (NEAC), assessed by a validated food frequency questionnaire at baseline, on the risk of 1) myocardial infarction and 2) osteoarthritis.
Identification of cases: Incident cases of myocardial infarction (ICD-10 code I21) and osteoarthritis (ICD-10 M15-19) were identified through exact linkages to the Swedish registries of population, migration, death, cancer, and inpatient care, using the national registration numbers as identifiers.
Main methods: The investigators fitted Cox proportional hazards regression models with age as underlying time scale to estimate hazard ratios (HR) with 95% confidence intervals (95% CI) for each outcome of interest at different levels of dietary NEAC. The investigators fitted multiple imputation models based on chained equations to address missingness of confounder variables.
- Conditions
- Myocardial Infarction, Diet, Osteoarthritis
- Being tested
- Total dietary NEAC assessed at baseline
- Keywords
- Antioxidants, Oxidative Stress, Atherosclerosis, Epidemiology
- Medical subject headings
- Myocardial Infarction, Osteoarthritis, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total dietary NEAC assessed at baselineOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial Infarction
Based on ICD-10 I21
Measured: October 1, 1997-December 31, 2010
Osteoarthritis
Based on ICD-10 M15-19
Measured: October 1, 1997-December 31, 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start1 Oct 1997
- Primary completion31 Dec 2010
- Study completion31 Dec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43,880 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ylva Trolle Lagerros, Karolinska Institutet
- Investigators
- Ylva Trolle Lagerros, MD, PhD, Principal investigator, Department of Medicine, Clinical Epidemiology, Karolinska Institutet; Department of Medicine, Clinic of Endocrinology, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03350568
- Sponsor's protocol ID
- 97-205
- Status last verified
- Nov 2017
- First submitted
- 19 Nov 2017
- Last updated
- 24 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study 1: Dietary Non Enzymatic Antioxidant Capacity and the Risk of Myocardial Infarction - The Swedish National March Cohort; Study 2: Dietary Total Antioxidant Capacity and Risk of Osteoarthritis in the Swedish National March Cohort
- ClinicalTrials.gov ID
- NCT03350568
- Acronym / sponsor ID
- 97-205
- Conditions
- Myocardial Infarction, Diet, Osteoarthritis
- Keywords
- Antioxidants, Oxidative Stress, Atherosclerosis, Epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43,880 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Oct 1997 (actual)
- Primary completion
- 31 Dec 2010 (actual)
- Study completion
- 31 Dec 2010 (actual)
- First posted
- 22 Nov 2017 (actual)
- 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.
Dietary antioxidants might protect from the development of chronic diseases by reducing levels of oxidative stress. The investigators therefore investigated the effect of dietary Non Enzymatic Antioxidant Capacity, which measures interactions between antioxidants in the whole diet, on the risk of 1) myocardial infarction and 2) osteoarthritis.
Detailed description
Aim: Among an initial sample of 43,880 men and women who participated in the Swedish National March Cohort in 1997 the investigators aimed to investigate the effect of dietary Non Enzymatic Antioxidant Capacity (NEAC), assessed by a validated food frequency questionnaire at baseline, on the risk of 1) myocardial infarction and 2) osteoarthritis.
Identification of cases: Incident cases of myocardial infarction (ICD-10 code I21) and osteoarthritis (ICD-10 M15-19) were identified through exact linkages to the Swedish registries of population, migration, death, cancer, and inpatient care, using the national registration numbers as identifiers.
Main methods: The investigators fitted Cox proportional hazards regression models with age as underlying time scale to estimate hazard ratios (HR) with 95% confidence intervals (95% CI) for each outcome of interest at different levels of dietary NEAC. The investigators fitted multiple imputation models based on chained equations to address missingness of confounder variables.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Study 1: Study population (n=34,543) was between the age of 18-94 years and free from cancer (except non-melanoma skin cancer) or any cardiovascular disease before the beginning of follow up. Study 2: Study population (n=29,188) was between the age of 40-94 years and free from osteoarthritis, bone cancer or -metastases , joint injury, or any arthropathy disease other than.
Key inclusion criteria (0 listed)
Key exclusion criteria (15 listed)
- Incorrect national registration number
- Subjects who were <18 years
- Emigration before beginning of follow-up
- Death before beginning of follow-up
- Cancer diagnosis
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 |
|---|---|---|
| Total dietary NEAC assessed at baseline | Other | – |
Primary outcome
Myocardial Infarction
Time frame: October 1, 1997-December 31, 2010
Based on ICD-10 I21
Osteoarthritis
Time frame: October 1, 1997-December 31, 2010
Based on ICD-10 M15-19
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 24 Nov 2017.
- Individual participant dataSharing planned: No
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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.
Ylva Trolle Lagerros, MD, PhD principal investigator
Department of Medicine, Clinical Epidemiology, Karolinska Institutet; Department of Medicine, Clinic of Endocrinology, Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction and Diet, run by Karolinska Institutet at 1 site in Sweden.
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 0 inclusion and 15 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 24 Nov 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 Sweden. 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. 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?
Myocardial Infarction (time frame: October 1, 1997-December 31, 2010). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Nov 2017.