- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03370432
Vitamin D, Genes and Colorectal Cancer
Associations Between Genetically Determined Low Vitamin D Level, Vitamin D Intake and Risk of Colorectal Cancer in a Prospective Case-cohort Study in Danes
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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.
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Colorectal cancer cases
1038 participants diagnosed with colorectal cancer from the Diet, Cancer and Health cohort.
|
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.
|
Information on diet, lifestyle, weight, height, medical treatment, environmental exposures, and other socio-economic factors were collected at enrolment using questionnaires and interviews
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of colorectal cancer in the DCH cohort
Tidsramme: 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
|
Between 1994 and 31th December 2009
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Vibeke Andersen, MD, PhD, University of Southern Denmark
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 19-Dvit
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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