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

Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01758081
• Other study ID #: AI093723
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2010
• Est. completion date: December 2023

Study information

• Verified date: August 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25874
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Human Cathelicidin Antimicrobial Peptide (hCAP-18)
• Infections

Intervention

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])

Dietary Supplement:
• Vitamin D3 placebo

• fish oil placebo

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	upper respiratory infection		one year
Primary	hCAP-18		one year
Secondary	lower respiratory infection		5 years
Secondary	urinary tract infection		5 years
Secondary	cellulitis		5 years
Secondary	antimicrobial-treated infection		5 years
Secondary	infection-related hospitalizations		5 years

External Links

•   VITAL study website