Vitamin D, Genes and Colorectal Cancer

Colorectal Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03370432
• Other study ID #: 19-Dvit
• Status: Completed
• Phase: N/A
• First received: December 6, 2017
• Last updated: December 15, 2017
• Start date: December 1993
• Est. completion date: December 2017

Study information

• Verified date: December 2017
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2895
• Est. completion date: December 2017
• Est. primary completion date: May 1997
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern Denmark	Danish Cancer Society

References & Publications (1)

Tjønneland A, Olsen A, Boll K, Stripp C, Christensen J, Engholm G, Overvad K. Study design, exposure variables, and socioeconomic determinants of participation in Diet, Cancer and Health: a population-based prospective cohort study of 57,053 men and women — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of colorectal cancer in the DCH cohort	Risk of coloractal cancer compared to healthy sub-cohort members and interaction with Vitamin D metabolizing genes and vitamin D intake	Between 1994 and 31th December 2009

External Links

•   Description of the Diet, Cancer and Health cohort