Vitamin D and Omega-3 Fatty Acids(VITAL Trial): Effects on Fractures

Summary

Principal Investigator: MERYL SUSAN LEBOFF
Abstract: DESCRIPTION (provided by applicant): Osteoporotic fractures are major public health problems that have been associated with low vitamin D levels. Previous data strongly suggest that doses of vitamin D = 700 IU/day reduce fractures and possibly falls. Basic and small clinical trials suggest that omega-3 fatty acids may also have beneficial skeletal effects, but effects on fractures are not known. Large primary prevention trials with high daily doses of vitamin D and/or omega-3 fatty acids in general populations (i.e., unselected for disease risk) are lacking. We propose an ancillary study to the VITAL study, a large, randomized, double-blind, placebo-controlled trial of vitamin D (in the form of vitamin D3 [cholecalciferol]) and/or marine omega-3 fatty acid (eicosapentaenoic acid [EPA] + docosahexaenoic acid [DHA]) supplements, to advance knowledge and test the effects of vitamin D3 (2000 IU/d) and/or fish oil (EPA+DHA, 1g/d) for primary prevention of fractures, bone loss, falls, and frailty. Growing enthusiasm for supplemental vitamin D to support bone health, and use of fish oil, which may also have skeletal effects, underscores the urgent need for a timely initiation of this ancillary study in conjunction with the newly funded VITAL parent study (U01CA 138962). The proposed ancillary study will include 20,000 women and men (>age 65 and 60, respectively) from the 5-year, NIH-sponsored, parent VITAL trial and a sub-cohort from that trial of 700 participants from Clinical and Translational Science Centers (CTSCs) in Boston, Chicago, Houston, and San Francisco to critically test these hypotheses: Primary Aims: In the VITAL cohort, will vitamin D3 and/or EPA+DHA reduce incident a) total fractures and b) hip or non-vertebral fractures? Secondary Aims: In the CTSC sub-cohort, will vitamin D3 and/or EPA+DHA reduce bone loss of the spine, hip, and total body, as assessed by Dual X-ray Absorptiometry at baseline and year 2 and do effects vary with (a) baseline and follow up blood levels of these nutrients, (b) gender, (c) race/skin pigmentation, and (d) body mass index? Tertiary Aims: In the VITAL cohort, will Vitamin D3 and/or EPA+DHA supplementation a) reduce the risk of falls as assessed by annual questionnaires and b) reduce frailty as determined by the questionnaire- based frailty index? Baseline and follow-up blood collections will be matched for season by month to prevent seasonal bias for vitamin D levels. In order to complete pre-randomization measurements among participants in the CTSC sites, it is essential that this ancillary study be undertaken in parallel to the parent VITAL trial placebo "run-in" to get baseline and follow-up measurements, which is scheduled to begin in mid-2010. This time-sensitive ancillary study will rigorously test the role of these nutritional supplements in improving skeletal health and will provide positive or informative null results on the effects of vitamin D and omega-3 fatty acids on fractures, bone density, falls, and frailty. We expect that findings from this ancillary study will inform clinical practice on whether high daily dose vitamin D and/or fish oil reduces the burden of age-related increases in fractures, which would result in widespread public health benefits.
Funding Period: 2010-09-17 - 2014-08-31
more information: NIH RePORT

Top Publications

  1. pmc 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 disease
    JoAnn 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

Detail Information

Publications1

  1. pmc 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 disease
    JoAnn 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
    ....

Research Grants30

  1. 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. ..
  2. Diabetes Prevention in the Vitamin D and Omega-3 Trial
    Yiqing Song; 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. VITAL-DEP: Depression Endpoint Prevention in the VITamin D and OmegA-3 TriaL
    OLIVIA IFEOMA OKEREKE; Fiscal Year: 2013
    ....
  5. 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. ..
  6. Vitamin D Effect on Body Composition During Behavioral Weight Loss in Women
    ANNE M MCTIERNAN; Fiscal Year: 2013
    ....
  7. Effects of Vitamin D and Marine Omega-3 Fatty Acids on Anemia in the Elderly
    Nancy Berliner; Fiscal Year: 2013
    ..abstract_text> ..
  8. Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Joint Pain
    Karen H Costenbader; Fiscal Year: 2013
    ....
  9. 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. ..
  10. EARLY EVENTS IN ALZHEIMER PATHOGENESIS
    SUE 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. ..
  11. Effects of Gastric Bypass Surgery on Calcium Metabolism and the Skeleton
    ANNE LOUISE SCHAFER; Fiscal Year: 2013
    ..Dr. Schafer is committed to improving the health care of veterans through clinical research, and the CDA-2 is critical for the attainment of her career objectives. ..
  12. 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. ..
  13. Centers of Research Translation (CoRT)
    Kenneth G Saag; Fiscal Year: 2013
    ..abstract_text> ..
  14. Racial/Ethnic Disparities in Fall Risk and Bone Strength Among Men
    Benedetta Bartali; Fiscal Year: 2013
    ..abstract_text> ..
  15. Impact of Amyloid on the Aging Brain
    Reisa A Sperling; Fiscal Year: 2013
    ..This PPG brings together an exceptional multidisciplinary team of clinical, statistical, cognitive neuroscience, imaging, and laboratory investigators dedicated to exploring the impact of amyloid on the aging brain. ..
  16. 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. ..