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Vitamin D, Genes and Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT03370432
Recruitment Status : Completed
First Posted : December 12, 2017
Last Update Posted : December 19, 2017
Sponsor:
Collaborator:
Danish Cancer Society
Information provided by (Responsible Party):
Vibeke Andersen, 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.

Condition or disease Intervention/treatment
Colorectal Cancer Other: Observational

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.

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Study Type : Observational
Actual Enrollment : 2895 participants
Observational Model: Other
Time Perspective: Prospective
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
Actual Study Start Date : December 1993
Actual Primary Completion Date : May 1997
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Colorectal cancer cases
1038 participants diagnosed with colorectal cancer from the Diet, Cancer and Health cohort.
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

Sub-cohort members
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.
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




Primary Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
DNA extracted from buffy coeats


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370432


Sponsors and Collaborators
University of Southern Denmark
Danish Cancer Society
Investigators
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Study Director: Vibeke Andersen, MD, PhD University of Southern Denmark
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vibeke Andersen, Clinical Professor, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT03370432    
Other Study ID Numbers: 19-Dvit
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vibeke Andersen, University of Southern Denmark:
Vitamin D
GC
CYP2R1
Gene-environment interaction
prospective case-cohort study
single nucleotide polymorphisms
colorectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases