InfectionsNCT01758081
Effects of Vitamin D and Omega-3 Fatty Acids on Infectious Diseases and hCAP18 (VITAL Infection)
A study testing vitamin D3 and omega-3 fatty acids (fish oil) in people with Infections and Human Cathelicidin Antimicrobial Peptide (hCAP-18), run by Brigham and Women's Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infections, Human Cathelicidin Antimicrobial Peptide (hCAP-18)
- What is being tested?
- vitamin D3 and omega-3 fatty acids (fish oil)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25,874 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Participants in VITAL (NCT 01169259) are eligible to participate in this ancillary study. Please see NCT 01169259 for lists of inclusion and exclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02215
About this study
Official title: 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.
- Being tested
- vitamin D3, omega-3 fatty acids (fish oil), Vitamin D3 placebo, fish oil placebo
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D3Dietary supplement
Vitamin D3 (cholecalciferol), 2000 IU per day
omega-3 fatty acids (fish oil)Drug
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])
Vitamin D3 placeboDietary supplement
fish oil placeboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| vitamin D + fish oil | Active comparator | vitamin D3 + Omacor Receives: Dietary Supplement: vitamin D3; Drug: omega-3 fatty acids (fish oil) |
| vitamin D + fish oil placebo | Active comparator | vitamin D3 + fish oil placebo Receives: Dietary Supplement: vitamin D3; Dietary Supplement: fish oil placebo |
| vitamin D placebo + fish oil | Active comparator | vitamin D placebo + Omacor Receives: Drug: omega-3 fatty acids (fish oil); Dietary Supplement: Vitamin D3 placebo |
| vitamin D placebo + fish oil placebo | Placebo comparator | vitamin D placebo + fish oil placebo Receives: Dietary Supplement: Vitamin D3 placebo; Dietary Supplement: fish oil placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
upper respiratory infection
Measured: one year
hCAP-18
Measured: one year
Secondary outcomes (5)
lower respiratory infection
Measured: 5 years
urinary tract infection
Measured: 5 years
cellulitis
Measured: 5 years
antimicrobial-treated infection
Measured: 5 years
infection-related hospitalizations
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study startJul 2010
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfectionsStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25,874 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos A. Camargo, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758081
- Sponsor's protocol ID
- AI093723
- Status last verified
- Sep 2025
- First submitted
- 24 Dec 2012
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21986389Bassuk 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.
PubMed 26767629
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vitamin D and Omega-3 Fatty Acids on Infectious Diseases and hCAP18
- ClinicalTrials.gov ID
- NCT01758081
- Acronym / sponsor ID
- AI093723
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25,874 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Jul 2010 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| vitamin D + fish oil | Active comparator | Dietary Supplement: vitamin D3, Drug: omega-3 fatty acids (fish oil)vitamin D3 + Omacor |
| vitamin D + fish oil placebo | Active comparator | Dietary Supplement: vitamin D3, Dietary Supplement: fish oil placebovitamin D3 + fish oil placebo |
| vitamin D placebo + fish oil | Active comparator | Drug: omega-3 fatty acids (fish oil), Dietary Supplement: Vitamin D3 placebovitamin D placebo + Omacor |
| vitamin D placebo + fish oil placebo | Placebo comparator | Dietary Supplement: Vitamin D3 placebo, Dietary Supplement: fish oil placebovitamin D placebo + fish oil placebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin D3Vitamin D3 (cholecalciferol), 2000 IU per day | Dietary supplement | vitamin D + fish oil, vitamin D + fish oil placebo |
| 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]) | Drug | vitamin D + fish oil, vitamin D placebo + fish oil |
| Vitamin D3 placebo | Dietary supplement | vitamin D placebo + fish oil, vitamin D placebo + fish oil placebo |
| fish oil placebo | Dietary supplement | vitamin D + fish oil placebo, vitamin D placebo + fish oil placebo |
Primary outcome
upper respiratory infection
Time frame: one year
hCAP-18
Time frame: one year
5 secondary outcomes
lower respiratory infection
Time frame: 5 years
urinary tract infection
Time frame: 5 years
cellulitis
Time frame: 5 years
antimicrobial-treated infection
Time frame: 5 years
infection-related hospitalizations
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Background: PubMed 21986389Manson 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.
- Background: PubMed 26767629Bassuk 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.
- VITAL study websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin D3 and omega-3 fatty acids (fish oil) in people with Infections and Human Cathelicidin Antimicrobial Peptide (hCAP-18), run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
upper respiratory infection (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01758081, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.