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

Primary Purpose

Infections, Human Cathelicidin Antimicrobial Peptide (hCAP-18)

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
vitamin D3
omega-3 fatty acids (fish oil)
Vitamin D3 placebo
fish oil placebo
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infections

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers
Participants in VITAL (NCT 01169259) are eligible to participate in this ancillary study. Please see NCT 01169259 for lists of inclusion and exclusion criteria.

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

vitamin D + fish oil

vitamin D + fish oil placebo

vitamin D placebo + fish oil

vitamin D placebo + fish oil placebo

Arm Description

vitamin D3 + Omacor

vitamin D3 + fish oil placebo

vitamin D placebo + Omacor

vitamin D placebo + fish oil placebo

Outcomes

Primary Outcome Measures

upper respiratory infection
hCAP-18

Secondary Outcome Measures

lower respiratory infection
urinary tract infection
cellulitis
antimicrobial-treated infection
infection-related hospitalizations

Full Information

First Posted
December 24, 2012
Last Updated
August 13, 2023
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01758081
Brief Title
Effects of Vitamin D and Omega-3 Fatty Acids on Infectious Diseases and hCAP18 (VITAL Infection)
Official Title
Effects of Vitamin D and Omega-3 Fatty Acids on Infectious Diseases and hCAP18
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2010 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Human Cathelicidin Antimicrobial Peptide (hCAP-18)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25874 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vitamin D + fish oil
Arm Type
Active Comparator
Arm Description
vitamin D3 + Omacor
Arm Title
vitamin D + fish oil placebo
Arm Type
Active Comparator
Arm Description
vitamin D3 + fish oil placebo
Arm Title
vitamin D placebo + fish oil
Arm Type
Active Comparator
Arm Description
vitamin D placebo + Omacor
Arm Title
vitamin D placebo + fish oil placebo
Arm Type
Placebo Comparator
Arm Description
vitamin D placebo + fish oil placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D3
Intervention Description
Vitamin D3 (cholecalciferol), 2000 IU per day
Intervention Type
Drug
Intervention Name(s)
omega-3 fatty acids (fish oil)
Intervention Description
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])
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3 placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
fish oil placebo
Primary Outcome Measure Information:
Title
upper respiratory infection
Time Frame
one year
Title
hCAP-18
Time Frame
one year
Secondary Outcome Measure Information:
Title
lower respiratory infection
Time Frame
5 years
Title
urinary tract infection
Time Frame
5 years
Title
cellulitis
Time Frame
5 years
Title
antimicrobial-treated infection
Time Frame
5 years
Title
infection-related hospitalizations
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21986389
Citation
Manson JE, Bassuk SS, Lee IM, Cook NR, Albert MA, Gordon D, Zaharris E, Macfadyen JG, Danielson E, Lin J, Zhang SM, Buring JE. 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. Contemp Clin Trials. 2012 Jan;33(1):159-71. doi: 10.1016/j.cct.2011.09.009. Epub 2011 Oct 2.
Results Reference
background
PubMed Identifier
26767629
Citation
Bassuk SS, Manson JE, Lee IM, Cook NR, Christen WG, Bubes VY, Gordon DS, Copeland T, Friedenberg G, D'Agostino DM, Ridge CY, MacFadyen JG, Kalan K, Buring JE. Baseline characteristics of participants in the VITamin D and OmegA-3 TriaL (VITAL). Contemp Clin Trials. 2016 Mar;47:235-43. doi: 10.1016/j.cct.2015.12.022. Epub 2016 Jan 6.
Results Reference
background
Links:
URL
http://www.vitalstudy.org/
Description
VITAL study website

Learn more about this trial

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

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