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Active, Not Recruiting

NCT Number: NCT03221127

Kuopio Ischaemic Heart Disease Risk Factor Study (Nutrition Component)

To determine associations between dietary factors and risk of major chronic diseases and their risk factors

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

STUDY POPULATION The Kuopio Ischaemic Heart Disease Risk Factor Study (KIHD) is an on-going prospective, population-based cohort study of risk factors for cardiovascular diseases, other chronic diseases and metabolic conditions in a sample of men from eastern Finland. The baseline examinations were carried out between 1984 and 1989, when 2,682 men (82.9% of those eligible) who were 42, 48, 54 or 60 years old were recruited. The first cohort consisted of 1166 men who were 54 years old, enrolled in 1984-1986, and the second cohort included 1516 men who were 42, 48, 54 or 60 years old, enrolled in 1986-1989. The baseline examinations were followed by the 4-year examinations (1991-1993), in which 1038 men from the second cohort (88% of the eligible) participated. At the 11-year examinations (1998-2001), all men from the second cohort were invited and 854 men (95% of the eligible) participated. These examinations were also the baseline for 920 postmenopausal women (78.4% of the 1173 eligible women) from the same area, aged 53-73 years. During the 20-year examination round, all men from the first and second baseline cohorts and all women were invited to the study site, and a total of 1241 men (80% of the eligible) and 634 women (81.0%) participated.

ASSESSMENT OF DIETARY INTAKES Food consumption has been assessed with an instructed food recording of four days, one of which was a weekend day, by household measures. A picture book of common foods and dishes was used to help in estimation of portion sizes. For each food item the participant could choose from 3-5 commonly used portion sizes or describe the portion size in relation to those in the book. In order to further improve accuracy, instructions were given and completed food records were checked by a nutritionist together with a participant. Nutrient intakes were estimated using the NUTRICA® 2.5 software (Social Insurance Institution, Turku, Finland). The databank of the software is mainly based on Finnish values of nutrient composition of foods.

OUTCOME ASSESSMENT Registration of the incidence of major chronic diseases and deaths during the follow up is based on the national registries (Hospital discharge registry, Cause of death register, Social Insurance Institution of Finland register for reimbursement of medicine expenses) by use of the Finnish personal identification code (social security number), and/or on findings at the re-examination rounds (such as fasting plasma glucose or 2-h oral glucose tolerance test to define type 2 diabetes in addition to data from the national registries).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 42, 48, 54 or 60 years (men at baseline in 1984-1989)
  • Aged 53 to 73 years (women at their baseline in 1998-2001)
  • Living in the city of Kuopio or neighboring rural areas

Exclusion criteria

  • Condition that prevented visit at study clinic

Treatment and study plan

Primary outcomes

  1. Cardiovascular disease

    Time frame: Annually between March 1984 and December 2052

    Incidence of cardiovascular disease

  2. Carotid atherosclerosis

    Time frame: From baseline to 4-y, 11-y and 20-y examinations

    Progression of common carotid artery - intima-media thickness (CCA-IMT)

  3. Death

    Time frame: Annually between March 1984 and December 2052

    Incidence of death

Secondary outcomes

  1. Type 2 diabetes

    Time frame: Annually between March 1984 and December 2052

    Incidence of type 2 diabetes

  2. Dementia

    Time frame: Annually between March 1984 and December 2052

    Incidence of dementia

  3. Cancer

    Time frame: Annually between March 1984 and December 2052

    Incidence of cancer

  4. Infectious disease

    Time frame: Annually between March 1984 and December 2052

    Incidence of hospitalization due infectious disease

Sponsors and collaborators

Lead sponsor

University of Eastern Finland

Other

Registry information

Important dates

Study start
1984
Primary completion
2052
Study completion
2052
First posted
Jul 18, 2017
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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