Dietary Antioxidants and Chronic Diseases-The Swedish National March Cohort

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03350568
• Other study ID #: 97-205
• Status: Completed
• Phase: N/A
• First received: November 19, 2017
• Last updated: November 22, 2017
• Start date: October 1, 1997
• Est. completion date: December 31, 2010

Study information

• Verified date: November 2017
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 infarction and 2) osteoarthritis.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43880
• Est. completion date: December 31, 2010
• Est. primary completion date: December 31, 2010
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diet
• Infarction
• Myocardial Infarction
• Osteoarthritis

Intervention

Other:
• Total dietary NEAC assessed at baseline

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial Infarction	Based on ICD-10 I21	October 1, 1997-December 31, 2010
Primary	Osteoarthritis	Based on ICD-10 M15-19	October 1, 1997-December 31, 2010