Clinical trial NCT03370432: Vitamin D, Genes and Colorectal Cancer
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: Vitamin D
GC
CYP2R1
Gene-environment interaction
prospective case-cohort study
single nucleotide polymorphisms
colorectal cancer
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
First posted: 2017-12-12
Enrollment: 2895
Sex: ALL
Minimum age (years): 50
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Diet, Cancer and Health study is an ongoing Danish cohort study designed to investigate the relation between diet, lifestyle and cancer risk. The cohort consists of 57,053 persons, recruited between December 1993 and May 1997. All the subjects were born in Denmark, and the individuals were 50 to 64 years of age and had no previous cancers at study entry. Blood samples, anthropometric measures and questionnaire data on diet and lifestyle were collected at study entry.

The present study uses a nested case-cohort design. Follow-up is based on population-based cancer registries. Between 1994 and 31th December 2009, 1038 CRC cases were diagnosed. A sub-cohort of 1857 persons has randomly been selected within the full cohort at time of entry into the cohort.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of colorectal cancer in the DCH cohort
timeFrame: Between 1994 and 31th December 2009
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Southern Denmark
name: Vibeke Andersen, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Tjonneland 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 in Denmark. Scand J Public Health. 2007;35(4):432-41. doi: 10.1080/14034940601047986.
citation: Kopp TI, Vogel U, Andersen V. Associations between common polymorphisms in CYP2R1 and GC, Vitamin D intake and risk of colorectal cancer in a prospective case-cohort study in Danes. PLoS One. 2020 Feb 3;15(2):e0228635. doi: 10.1371/journal.pone.0228635. eCollection 2020.