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

Effects of Vitamin D and Omega-3 Fatty Acids on Infectious Diseases and hCAP18

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Infections; Human Cathelicidin Antimicrobial Peptide (hCAP-18)
• Intervention / Treatment: Dietary supplement: Vitamin D3 placebo; Dietary supplement: vitamin D3; Drug: omega-3 fatty acids (fish oil); Dietary supplement: fish oil placebo

• Study Type: Interventional
• Enrollment (Actual): 25874
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Participants in VITAL (NCT 01169259) are eligible to participate in this ancillary study. Please see NCT 01169259 for lists of inclusion and exclusion criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / 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	Dietary supplement: Vitamin D3 placebo; 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])
Placebo Comparator: vitamin D placebo + fish oil placebo	Dietary supplement: Vitamin D3 placebo; Dietary supplement: fish oil placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
upper respiratory infection	one year
hCAP-18	one year

Secondary Outcome Measures

Outcome Measure	Time Frame
lower respiratory infection	5 years
urinary tract infection	5 years
cellulitis	5 years
antimicrobial-treated infection	5 years
infection-related hospitalizations	5 years

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• VITAL Study Website

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2010
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: December 24, 2012
• First Submitted That Met QC Criteria: December 24, 2012
• First Posted (Estimated): January 1, 2013

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 13, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: AI093723