NCT03266887

Brief Summary

Using the population-based data sources in Iceland and the well-characterized AGES-Reykjavik cohort, our overarching aims are on exploring whether pre-diagnostic serum levels of 25-hydroxyvitamin D (25(OH)D) among older individuals living in Iceland were associated with survival after cancer diagnosis. We also wanted to assess the risk of being diagnosed with cancer in association with 25(OH)D levels. In this population living just south of the arctic circle, vitamin D levels largely depend on dietary- and supplemental sources.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,764

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2002

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2006

Completed
10.7 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2017

Completed
Last Updated

August 30, 2017

Status Verified

August 1, 2017

Enrollment Period

5 years

First QC Date

August 28, 2017

Last Update Submit

August 28, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Overall mortality among cancer patients

    We tested the association between pre-diagnostic 25(OH)D levels and total survival

    Patients were followed from date of diagnosis since 2002 until death or censored at end of the follow-up (December 31, 2014)

Secondary Outcomes (1)

  • Cancer-specific mortality among cancer patients

    Patients were followed from date of diagnosis since 2002 until death or censored at end of the follow-up (December 31, 2014)

Other Outcomes (1)

  • Pre-diagnostic 25(OH)D levels and cancer risk

    Participants without cancer were followed from the study entry since 2002 until cancer diagnosis, death or end of the observation period whichever occurred first (December 31, 2014)

Eligibility Criteria

Age66 Years - 98 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

In 1967, all 30,795 men and women living in the capital area of Iceland and born between 1907 and 1935 were invited by the Icelandic Heart Association to join a prospective cohort study. Approximately 19,000 attended the clinic at least once and became participants of the Reykjavik Study. Subsequently, in 2002, a random sample of the cohort comprising 5,764 men and women who were still alive in Iceland and aged 66 to 96 years entered the Ages Gene/Environment Susceptibility (AGES) - Reykjavik Study (20). Serum 25(OH)D was measured in 5,519 of all 5,764 (96%) participants at study entry in year 2002 through 2006.

You may qualify if:

  • To be part of the AGES-Reykjavik Study, initiated between 2002 and 2006.

You may not qualify if:

  • Diagnosed with cancer at study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Serum

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2017

First Posted

August 30, 2017

Study Start

January 1, 2002

Primary Completion

December 30, 2006

Study Completion

December 30, 2006

Last Updated

August 30, 2017

Record last verified: 2017-08