Vitamin D, Genes and Colorectal Cancer

Completed

• Conditions: Colorectal Cancer
• Interventions: Other: Observational

• Registration Number: NCT03370432
• Lead Sponsor: University of Southern Denmark

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 1993-12
• Primary Completion: 1997-05
• Status Verified: 2017-12
• Study Completion: 2017-12
• Study First Submitted: 2017-12-06
• Study First Submitted QC: 2017-12-06
• Study First Posted: 2017-12-12
• Last Update Submitted: 2017-12-15
• Last Update Posted: 2017-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2895

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sub-cohort members	Observational	1857 persons randomly selected within the full cohort at time of entry into the Diet, Cancer and Health cohort. These participants serve as controls for the colorectal cancer cases.
Colorectal cancer cases	Observational	1038 participants diagnosed with colorectal cancer from the Diet, Cancer and Health cohort.

Primary Outcome Measures

Name	Time	Method
Incidence of colorectal cancer in the DCH cohort	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