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

Study Overview
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Brief Summary
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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.

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

Conditions
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Infections, Human Cathelicidin Antimicrobial Peptide (hCAP-18)

Intervention / Treatment
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* Dietary Supplement: vitamin D3
* Drug: omega-3 fatty acids (fish oil)
* Dietary Supplement: Vitamin D3 placebo
* Dietary Supplement: fish oil placebo


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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: vitamin D + fish oil<br>vitamin D3 + Omacor | Dietary Supplement: vitamin D3<br>* Vitamin D3 (cholecalciferol), 2000 IU per day<br>Drug: omega-3 fatty acids (fish oil)<br>* 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])<br>|
| Active Comparator: vitamin D + fish oil placebo<br>vitamin D3 + fish oil placebo | Dietary Supplement: vitamin D3<br>* Vitamin D3 (cholecalciferol), 2000 IU per day<br>Dietary Supplement: fish oil placebo<br> <br> |
| Active Comparator: vitamin D placebo + fish oil<br>vitamin D placebo + Omacor | Drug: omega-3 fatty acids (fish oil)<br>* 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])<br>Dietary Supplement: Vitamin D3 placebo<br> <br> |
| Placebo Comparator: vitamin D placebo + fish oil placebo<br>vitamin D placebo + fish oil placebo | Dietary Supplement: Vitamin D3 placebo<br> <br> Dietary Supplement: fish oil placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |