Diabetes Prevention in the Vitamin D and Omega-3 Trial
Principal Investigator: Yiqing Song
Abstract: DESCRIPTION (provided by applicant): We propose to evaluate the balance of benefits and risks of vitamin D3 (2,000 IU/day) and marine omega-3 fatty acid (eicosapentaenoic acid [EPA] + docosahexaenoic acid [DHA], 1g/day) supplements in reducing risk of T2D in the setting of an NIH-funded large-scale randomized trial, the VITamin D and OmegA-3 TriaL (VITAL). The VITAL trial is a randomized, double-blind, placebo-controlled trial specifically designed to evaluate the efficacy of vitamin D and marine omega-3 fatty acid supplements in the primary prevention of cancer and cardiovascular disease (CVD) among 20,000 U.S. men and women. We will test the hypothesis that vitamin D or omega-3 supplementation reduces the risk of T2D among initially non-diabetic subjects participating in the trial. We will further assess whether and to what extent vitamin D or omega-3 supplementation improves glucose tolerance and insulin sensitivity/secretion in a subset of the cohort undergoing biomarker evaluation for these endpoints. Hence, we propose a cost-effective strategy to evaluate the efficacy of the study interventions for diabetes prevention as well as to provide detailed characterization of the physiologic mechanisms that may impart this benefit. Case validation of incident T2D will require collection of detailed diagnostic information from medical record review and/or supplementary questionnaires completed by the participants'physicians. To complement case validation, additional data on diabetes diagnoses and hypoglycemic medication will be retrieved by linking the trial participants with the Centers for Medicare and Medicaid Services (CMS) database. In our substudy, 1,000 participants without a report of diabetes at baseline recruited at four Clinical and Translational Science Center (CTSC) sites across the U.S. (Boston, Chicago, San Francisco, and Houston) will undergo a standard 2-hour oral glucose tolerance test (OGTT) at baseline (pre- randomization) and at 2 years of follow-up (matched for season, by month). Serial measurements of insulin and glucose homeostasis will thereby be ascertained. Glycated hemoglobin A1c (HbA1c) will also be measured. In summary, we believe that the research infrastructure of the parent VITAL trial will offer us a unique cost-effective opportunity to answer important and timely questions about potential benefits of vitamin D or omega-3 fatty acid supplementation in the prevention of T2D, as well as to identify potential risks. In this proposed ancillary study, we request funds to perform diabetes case validation in the VITAL cohort and serial glucose tolerance testing at baseline and follow-up in a subsample. In order to complete pre-randomization assessment of glucose tolerance among participants at the CTSC sites, it is critically important that this ancillary study be undertaken parallel to the placebo "run-in" enrollment period for the parent VITAL trial, which is scheduled to begin in April 2010.
Funding Period: 2010-09-15 - 2015-06-30
more information: NIH RePORT
- The VITamin D and OmegA-3 TriaL (VITAL): rationale and design of a large randomized controlled trial of vitamin D and marine omega-3 fatty acid supplements for the primary prevention of cancer and cardiovascular diseaseJoAnn E Manson
Division of Preventive Medicine, Department of Medicine, Brigham and Women s Hospital, Harvard Medical School, 900 Commonwealth Avenue East, Boston, MA 02215, United States
Contemp Clin Trials 33:159-71. 2012....
- Circulating 25-hydroxy-vitamin D and risk of cardiovascular disease: a meta-analysis of prospective studiesLu Wang
Brigham and Women s Hospital, Boston, MA 02215, USA
Circ Cardiovasc Qual Outcomes 5:819-29. 2012..Vitamin D status has been linked to the risk of cardiovascular disease (CVD). However, the optimal 25-hydroxy-vitamin D (25[OH]-vitamin D) levels for potential cardiovascular health benefits remain unclear...
- Blood 25-hydroxy vitamin D levels and incident type 2 diabetes: a meta-analysis of prospective studiesYiqing Song
Department of Medicine, Harvard Medical School, Boston, MA, USA
Diabetes Care 36:1422-8. 2013..To quantitatively assess the strength and shape of the association between blood 25-hydroxy vitamin D [25(OH)D] levels and incident risk of type 2 diabetes...
- A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive DeclineJae H Kang; Fiscal Year: 2013..We propose an exciting substudy, incorporating cognitive testing among VITAL participants aged 65+ years to evaluate whether marine omega-3 fatty and vitamin D may be important in the maintenance of cognitive function in men and women. ..
- VITAL-DEP: Depression Endpoint Prevention in the VITamin D and OmegA-3 TriaLOLIVIA IFEOMA OKEREKE; Fiscal Year: 2013....
- Vitamin D and type 2 diabetes (D2d)Anastassios G Pittas; Fiscal Year: 2013....
- Effect of Vitamin D and Omega-3 Fatty Acids on Blood Pressure and HypertensionHoward D Sesso; Fiscal Year: 2013..Because high blood pressure is responsible for one out of every six deaths in the United States, the results of this study could possibly improve the health of many people. ..
- Effects of Vitamin D and Marine Omega-3 Fatty Acids on Anemia in the ElderlyNancy Berliner; Fiscal Year: 2013..abstract_text> ..
- The VITAL Rhythm StudyChristine M Albert; Fiscal Year: 2013..If either agent significantly lowers AF risk, then these agents would represent one of the first therapies proven effective for the primary prevention of this growing morbid disease. ..
- EARLY EVENTS IN ALZHEIMER PATHOGENESISSUE TILTON GRIFFIN; Fiscal Year: 2013..The synergy between our aims, approaches, and measures will enable us to meet our goal of defining early cellular interactions toward development of rational interventions in AD. ..
- JHU-UMD Diabetes Research CenterFredric E Wondisford; Fiscal Year: 2013..The Enrichment Program will facilitate the interaction within and between Johns Hopkins University and the University of Maryland. ..
- Hopkins Center for Eliminate Cardiovascular Health DisparitiesLisa A Cooper; Fiscal Year: 2013..abstract_text> ..
- Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Joint PainKaren H Costenbader; Fiscal Year: 2013....
- Effects of vitamin D and omega-3 fatty acids on infectious diseases and hCAP18Carlos A Camargo; Fiscal Year: 2013..The findings may have direct clinical and public health impact for the prevention of infections in older adults. ..
- Lung VITamin D and OmegA-3 TriaL (Lung VITAL)Diane R Gold; Fiscal Year: 2013..If vitamin D or marine omega-3 fatty acid supplementation reduce COPD and asthma exacerbations, reduce decline of lung function, improve asthma control and/or reduce pneumonia risk, this would be of great benefit to public health. ..
- Center of Excellence for Health Disparties in the Nation's CapitalPHYLLIS R MAGRAB; Fiscal Year: 2013..The important cross-cutting objectives of Cultural Competence intersect with each of these areas. ..
- BIOLOGY OF NEUROENDOCRINE PEPTIDESMarc R Montminy; Fiscal Year: 2013..Specifying the contributions of the CRF family of ligands and receptors to the maintenance of homeostasis and to stress-linked allostasis may improve our ability to manage diseases, including mood and metabolic disorders ..