Dietary Antioxidants and Chronic Diseases-The Swedish National March Cohort

Sponsor
Karolinska Institutet (Other)
Overall Status
Completed
CT.gov ID
NCT03350568
Collaborator
(none)
43,880
1
159
276

Study Details

Study Description

Brief 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 infarction and 2) osteoarthritis.

Condition or Disease Intervention/Treatment Phase
  • Other: Total dietary NEAC assessed at baseline

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

Study Type:
Observational
Actual Enrollment :
43880 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Oct 1, 1997
Actual Primary Completion Date :
Dec 31, 2010
Actual Study Completion Date :
Dec 31, 2010

Outcome Measures

Primary Outcome Measures

  1. Myocardial Infarction [October 1, 1997-December 31, 2010]

    Based on ICD-10 I21

  2. Osteoarthritis [October 1, 1997-December 31, 2010]

    Based on ICD-10 M15-19

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Exclusion Criteria Study 1:
  • 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

  • Extreme energy intake

Exclusion Criteria Study 2:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Karolinska Institutet Stockholm Sweden

Sponsors and Collaborators

  • Karolinska Institutet

Investigators

  • Principal Investigator: Ylva Trolle Lagerros, MD, PhD, Department of Medicine, Clinical Epidemiology, Karolinska Institutet; Department of Medicine, Clinic of Endocrinology, Karolinska University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ylva Trolle Lagerros, MD, Associate Professor, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT03350568
Other Study ID Numbers:
  • 97-205
First Posted:
Nov 22, 2017
Last Update Posted:
Nov 24, 2017
Last Verified:
Nov 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ylva Trolle Lagerros, MD, Associate Professor, Karolinska Institutet
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 24, 2017