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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Carlos A. Camargo, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01758081
First received: December 24, 2012
Last updated: January 1, 2013
Last verified: January 2013
History of Changes
  Purpose

The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in 20,000 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or fish oil (1 gram of omega-3 fatty acids) 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 fish oil affect risk of infection and plasma hCAP18 levels.


Condition Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Vitamin D and Omega-3 Fatty Acids on Infectious Diseases and hCAP18

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • upper respiratory infection [ Time Frame: one year ] [ Designated as safety issue: No ]
  • hCAP-18 [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • lower respiratory infection [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • urinary tract infection [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • cellulitis [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • antimicrobial-treated infection [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • infection-related hospitalizations [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 20000
Study Start Date: July 2010
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01758081

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

Additional Information:
VITAL study website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Carlos A. Camargo, Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01758081     History of Changes
Other Study ID Numbers: AI093723
Study First Received: December 24, 2012
Last Updated: January 1, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Communicable Diseases
Infection
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
 Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on June 18, 2013