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Completed

NCT Number: NCT03370432

Vitamin D, Genes and Colorectal Cancer

The aim of this study is to investigate the interaction between intake of vitamin D and polymorphisms in GC and CYP2R1 in relation to risk of colorectal cancer in a Danish prospective cohort study.

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Key information

About this study

The association between vitamin D and incidence of colorectal cancer (CRC) has been thoroughly investigated in both observational and experimental studies, but the results are conflicting. Genetic epidemiology is an advantageous alternative to randomized, clinical trials for ethical and economic reasons.

The aim of this study is to investigate whether polymorphisms in GC and CYP2R1 that predicts 25-hydroxycholecalciferol (25(OH)D) concentrations after both ultraviolet B radiation and consumption of vitamin D3-fortified bread and milk in Danes are associated with risk of CRC; and further, to examine whether intake of vitamin D through diet and supplementation alter the risk of CRC.

Data are retrieved from the Danish prospective "Diet, Cancer and Health" study encompassing 57,053 persons which were recruited between 1993 to 1997. Between 1994 and 31th December 2009, 1038 CRC cases has been diagnosed. A sub-cohort of 1857 persons has been randomly selected within the full cohort at time of entry into the cohort. The study design is a nested case-cohort study.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Born in Denmark
  • No previous cancers at study entry
  • Age between 50-64

Exclusion criteria

  • Previous or present cancer(s) at study entry

Treatment and study plan

Observational

Other

Information on diet, lifestyle, weight, height, medical treatment, environmental exposures, and other socio-economic factors were collected at enrolment using questionnaires and interviews

Primary outcomes

  1. Incidence of colorectal cancer in the DCH cohort

    Time frame: Between 1994 and 31th December 2009

    Risk of coloractal cancer compared to healthy sub-cohort members and interaction with Vitamin D metabolizing genes and vitamin D intake

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Danish Cancer Society

Registry information

Official study title

Associations Between Genetically Determined Low Vitamin D Level, Vitamin D Intake and Risk of Colorectal Cancer in a Prospective Case-cohort Study in Danes

Important dates

Study start
1993
Primary completion
1997
Study completion
2017
First posted
Dec 12, 2017
Registry last updated
Dec 19, 2017

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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