Grant Abstract: VITamin D and OmegA-3 TriaL (VITAL)

Grant Number: 5R01CA138962-09
PI Name: Manson
Project Title: VITamin D and OmegA-3 TriaL (VITAL)

Abstract: This supplement falls within the scope of the parent grant (R01 CA138962; The VITAmin D and Omega-3 Trial) and enhances the trial’s overall impact. The goal of the parent VITAL trial is to clarify the role of vitamin D and marine omega-3 fatty acid supplements in the primary prevention of cancer and CVD in men and women.
In this supplement, we propose:
Aim 1) To add a 4-5 year blood collection and follow-up visit in the VITamin D and OmegA-3 TriaL (VITAL) among the 1054 participants who are evaluated as part of the trial’s Clinical and Translational Science Center (CTSC) component. As the main VITAL trial intervention phase is ending in December 2017, this proposal is time-urgent with the goal of starting the follow-up visits in fall 2016 and completing them within one year, by fall 2017.
Aim 2) To request two more years of Medicare claims data in addition to the years 2011-2013 that we currently have, in order to enhance and supplement outcomes data (primary and secondary endpoints for main VITAL and its ancillary studies) reported by VITAL participants, to achieve more complete ascertainment of trial endpoints.
Aim 3) To measure levels of important emerging biomarkers of vitamin D activity (vitamin D-binding protein [DBP] and free 25 hydroxyvitamin D [25-OH D]), and calculate bioavailable 25-OH D, in a nested case-cohort study of the VITAL trial comprising 2000 incident cases of cancer and cardiovascular disease (CVD) and 1000 controls, to assess whether baseline levels are related to risk of these outcomes or modify the effect of the vitamin D intervention.

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