Omega-3 Fatty Acids for Prevention of Dry Eye Disease: VITAL-DED


Principal Investigator: Debra A Schaumberg
Abstract: DESCRIPTION (provided by applicant): Dry eye disease (DED) is an important and prevalent public health concern for older Americans that is associated with nearly $4 billion in direct and $55 billion in indirect costs annually. VITAL-DED proposes to study the efficacy of marine omega-3 fatty acid (FA) supplementation for the prevention of DED, as well as the long-term amelioration of its associated chronic ocular surface pain and quality of life impacts, which include problems reading and driving. The study will leverage invaluable resources and data from the VITamin D and OmegA-3 TriaL (VITAL, 1U01CA138962), a randomized, double-blind, placebo-controlled, 2x2 factorial trial to test marine omega-3 FA (465 mg/d eicosapentaenoic acid + 375 mg/d docosahexaenoic acid) and vitamin D3 (cholecalciferol, 2000 IU/d) supplements in the primary prevention of cancer and cardiovascular disease among 20,000 men and women aged >50 y &>55 y, respectively. Beginning in July 2011 and continuing throughout 2012, willing and eligible respondents to an invitational mailing will be enrolled in a month run-in, and subsequently those who remain willing, eligible, and compliant during the run-in will be randomly assigned to omega-3 FA or a matching placebo and vitamin D3 or a matching placebo. At 1-year intervals, participants will receive a new supply of pills and a follow up questionnaire on compliance, side effects, and incidence of health endpoints. We propose to ascertain prevalent (pre-randomization) and incident (post-randomization) DED endpoints in the VITAL trail. The primary Specific Aims of VITAL-DED are to test whether omega-3 FA supplementation: 1) reduces the incidence of DED, 2) improves the natural history of DED by relieving symptoms and other impacts on quality of life. Secondary Aims will estimate the incidence of DED in the US, prospectively examine the natural history of DED, explore factors that could modify or influence the impact of omega-3 FA supplementation, evaluate the inter-relationship of DED and depression, and test for possible independent or joint effects of vitamin D3 supplementation in the incidence and natural history of DED. This research is responsive to a program priority of the National Eye Institute's Strategic Plan to improve our understanding of and develop preventive strategies for inflammatory corneal and ocular surface diseases;and also addresses several issues identified in the recent 2010 NEI Workshop on Ocular Pain and Sensitivity. The hypotheses are supported by a compelling biological rationale and strong preliminary data from our prior epidemiological studies, as well as from laboratory investigations and small randomized trials, which suggest that omega-3 FA supplementation, could prevent DED and improve its natural history. We believe the timely start of VITAL-DED offers a unique but time-sensitive opportunity to obtain a reliable, efficient, and informative evaluation of the efficacy of the most promising preventive agent for DED. Given our success with prior large simple trials, our experience with DED, and our proposed methodology, we think VITAL-DED will provide definitive results to guide public health and clinical recommendations for DED prevention and management. PUBLIC HEALTH RELEVANCE: The ultimate goal of the proposed research is to accelerate the identification and availability of a safe and effective strategy to prevent dry eye disease (DED) and improve its natural history. This is important because DED is very common among older Americans, causing chronic ocular pain, an increased risk of infection, and problems with activities such as reading and driving. Existing evidence points to omega-3 fatty acids as the most promising agent to test for DED prevention and therapy, and we will take advantage of the incomparable opportunity offered by the VITAL trial (VITamin D and OmegA-3 TriaL), a large randomized trial of 20,000 older men and women to evaluate whether a supplement of omega-3 fatty acids versus a placebo can prevent DED and improve people's quality of life.
Funding Period: 2012-09-01 - 2017-08-31
more information: NIH RePORT

Detail Information

Research Grants34

  1. VITAL-AMD: Prevention of AMD in the VITamin D and OmegA-3 Trial
    Debra A Schaumberg; Fiscal Year: 2013
    ..Findings from this large clinical trial will clarify the role of vitamin D and omega-3 fatty acid supplements in he prevention of AMD, the leading cause of blindness in US men and women. ..
  2. Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Joint Pain
    Karen H Costenbader; Fiscal Year: 2013
  3. A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline
    Jae 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. ..
  4. Vitamin D and Omega-3 Fatty Acids(VITAL Trial): Effects on Fractures
    MERYL SUSAN LEBOFF; Fiscal Year: 2013
  5. Effect of Vitamin D and Omega-3 Fatty Acids on Blood Pressure and Hypertension
    Howard 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. ..
  6. VITamin D and OmegA-3 TriaL: Effects on Bone Structure and Architecture
    MERYL SUSAN LEBOFF; Fiscal Year: 2013
    ..Findings from this proposal will fill gaps in knowledge and inform clinical and public health recommendations. ..
  7. Diabetes Prevention in the Vitamin D and Omega-3 Trial
    Yiqing Song; Fiscal Year: 2013
  8. The VITAL Rhythm Study
    Christine 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. ..
  9. Depression, Estrogen Replacement, and Cardiovascular Health in the Perimenopause
    David R Rubinow; Fiscal Year: 2013
    ..abstract_text> ..
    Scott T Weiss; Fiscal Year: 2013
    ..This intervention is cheap, safe, and will result in major public health benefit. It also represents the most innovative and novel approach to asthma treatment and prevention in the last 30 years. ..
  11. Hopkins Center for Eliminate Cardiovascular Health Disparities
    Lisa A Cooper; Fiscal Year: 2013
    ..abstract_text> ..
  12. Effects of Vitamin D and Marine Omega-3 Fatty Acids on Anemia in the Elderly
    Nancy Berliner; Fiscal Year: 2013
    ..abstract_text> ..
  13. Effects of vitamin D and omega-3 fatty acids on infectious diseases and hCAP18
    Carlos A Camargo; Fiscal Year: 2013
    ..The findings may have direct clinical and public health impact for the prevention of infections in older adults. ..
  14. Notch-Mediated Expansion of Cord Blood Progenitors for Stem Cell Transplant
    Colleen Delaney; Fiscal Year: 2013
    ..Our goal is to now determine the clinical efficacy of this approach in a phase II clinical trial. ..
  15. 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. ..
    Marc 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 ..
  17. VITAL-DEP: Depression Endpoint Prevention in the VITamin D and OmegA-3 TriaL
    OLIVIA IFEOMA OKEREKE; Fiscal Year: 2013