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Effects of Vitamin D and Omega-3 Fatty Acids on Infectious Diseases and hCAP18 (VITAL Infection)

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ClinicalTrials.gov Identifier: NCT01758081
Recruitment Status : Active, not recruiting
First Posted : January 1, 2013
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
Carlos A. Camargo, Brigham and Women's Hospital

Brief Summary:
The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial in 25,875 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. This ancillary study is being conducted among participants in VITAL and will examine whether vitamin D or omega-3 fatty acids affect risk of infection and plasma hCAP18 levels.

Condition or disease Intervention/treatment Phase
Infections Human Cathelicidin Antimicrobial Peptide (hCAP-18) Dietary Supplement: vitamin D3 Drug: omega-3 fatty acids (fish oil) Dietary Supplement: Vitamin D3 placebo Dietary Supplement: fish oil placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25874 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Vitamin D and Omega-3 Fatty Acids on Infectious Diseases and hCAP18
Actual Study Start Date : July 2010
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: vitamin D + fish oil
vitamin D3 + Omacor
Dietary Supplement: vitamin D3
Vitamin D3 (cholecalciferol), 2000 IU per day
Drug: omega-3 fatty acids (fish oil)
Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA])
Active Comparator: vitamin D + fish oil placebo
vitamin D3 + fish oil placebo
Dietary Supplement: vitamin D3
Vitamin D3 (cholecalciferol), 2000 IU per day
Dietary Supplement: fish oil placebo
Active Comparator: vitamin D placebo + fish oil
vitamin D placebo + Omacor
Drug: omega-3 fatty acids (fish oil)
Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA])
Dietary Supplement: Vitamin D3 placebo
Placebo Comparator: vitamin D placebo + fish oil placebo
vitamin D placebo + fish oil placebo
Dietary Supplement: Vitamin D3 placebo Dietary Supplement: fish oil placebo



Primary Outcome Measures :
  1. upper respiratory infection [ Time Frame: one year ]
  2. hCAP-18 [ Time Frame: one year ]

Secondary Outcome Measures :
  1. lower respiratory infection [ Time Frame: 5 years ]
  2. urinary tract infection [ Time Frame: 5 years ]
  3. cellulitis [ Time Frame: 5 years ]
  4. antimicrobial-treated infection [ Time Frame: 5 years ]
  5. infection-related hospitalizations [ Time Frame: 5 years ]


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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
Participants in VITAL (NCT 01169259) are eligible to participate in this ancillary study. Please see NCT 01169259 for lists of inclusion and exclusion criteria.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01758081


Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Brigham and Women's Hospital