Dry Eye DiseaseNCT01880463
Dry Eye Disease in the Vitamin D and Omega-3 Trial (VITAL)
A study testing Omega-3 fatty acids (fish oil) and Vitamin D3 in people with Dry Eye Disease, run by Brigham and Women's Hospital.
Trial summary
The VITamin D and OmegA-3 Trial (VITAL; NCT 01169259) is a 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… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- Omega-3 fatty acids (fish oil) and Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25,875 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- All participants in VITAL (NCT 01169259) are eligible to participate in this ancillary study.
Who cannot join
- None
About this study
The VITamin D and OmegA-3 Trial (VITAL; NCT 01169259) is a 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 omega-3 fatty acids or vitamin D3, compared to placebo, reduce the incidence and/or progression of dry eye disease.
Read the detailed description
This ancillary study to VITAL will examine the efficacy of omega-3 fatty acids and vitamin D3 in prevention of dry eye disease. The primary aims are to test whether omega-3 fatty acid supplementation (1) reduces the incidence of dry eye disease, and (2) improves the natural history of dry eye disease by relieving symptoms and other impacts on quality of life. Secondary aims are to estimate the incidence of dry eye disease in the US, prospectively examine the natural history of dry disease, explore factors that could modify or influence the impact of omega-3 fatty acid supplementation, evaluate the interrelationship of dry eye disease and depression, and test for possible independent or joint effects of vitamin D3 supplementation in the incidence and natural history of dry eye disease.
- Conditions
- Dry Eye Disease
- Being tested
- Omega-3 fatty acids (fish oil), Vitamin D3, Vitamin D3 placebo, Fish oil placebo
- Keywords
- Dry eye disease, incidence, progression
- Medical subject headings
- Dry Eye Syndromes, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 fatty acids (fish oil)Drug
Also called Omacor
Vitamin D3Dietary supplement
Also called cholecalciferol
Vitamin D3 placeboDietary supplement
Fish oil placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D + fish oil placebo | Active comparator | Vitamin D3 (cholecalciferol), 2000 IU per day
Fish oil placebo Receives: Dietary Supplement: Vitamin D3; Drug: Fish oil placebo |
| Vitamin D placebo + fish oil | Active comparator | Vitamin D placebo
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]) 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; Drug: Fish oil placebo |
| Vitamin D + fish oil | Active comparator | Vitamin D (cholecalciferol), 2000 IU per day
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]) Receives: Drug: Omega-3 fatty acids (fish oil); Dietary Supplement: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dry Eye Disease
Report of a diagnosis of dry eye disease confirmed by medical record review.
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 posted19 Jun 2013 (estimated)
- Study startJul 2010
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry Eye DiseaseStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25,875 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Principal investigator, Debra Ann Schaumberg, ScD, OD, MPH, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880463
- Sponsor's protocol ID
- 2012P001332
- Other IDs
- R01EY022663
- Status last verified
- Jul 2019
- First submitted
- 15 Jun 2013
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Christen WG, Cook NR, Manson JE, Buring JE, Lee IM, Bubes V, Friedenberg G, Dushkes R, Smith D, Schaumberg DA; VITAL Research Group. Efficacy of Marine omega-3 Fatty Acid Supplementation vs Placebo in Reducing Incidence of Dry Eye Disease in Healthy US Adults: A Randomized Clinical Trial. JAMA Ophthalmol. 2022 Jul 1;140(7):707-714. doi: 10.1001/jamaophthalmol.2022.1818.
PubMed 35679030
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dry Eye Disease in the Vitamin D and Omega-3 Trial (VITAL)
- ClinicalTrials.gov ID
- NCT01880463
- Acronym / sponsor ID
- 2012P001332
- Conditions
- Dry Eye Disease
- Keywords
- Dry eye disease, incidence, progression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25,875 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- Jul 2010
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 19 Jun 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 a 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 omega-3 fatty acids or vitamin D3, compared to placebo, reduce the incidence and/or progression of dry eye disease.
Detailed description
This ancillary study to VITAL will examine the efficacy of omega-3 fatty acids and vitamin D3 in prevention of dry eye disease. The primary aims are to test whether omega-3 fatty acid supplementation (1) reduces the incidence of dry eye disease, and (2) improves the natural history of dry eye disease by relieving symptoms and other impacts on quality of life. Secondary aims are to estimate the incidence of dry eye disease in the US, prospectively examine the natural history of dry disease, explore factors that could modify or influence the impact of omega-3 fatty acid supplementation, evaluate the interrelationship of dry eye disease and depression, and test for possible independent or joint effects of vitamin D3 supplementation in the incidence and natural history of dry eye disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vitamin D + fish oil placebo | Active comparator | Dietary Supplement: Vitamin D3, Drug: Fish oil placeboVitamin D3 (cholecalciferol), 2000 IU per day 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, 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 D placebo + fish oil placebo | Placebo comparator | Dietary Supplement: Vitamin D3 placebo, Drug: Fish oil placeboVitamin D placebo fish oil placebo |
| Vitamin D + fish oil | Active comparator | Drug: Omega-3 fatty acids (fish oil), Dietary Supplement: Vitamin D3Vitamin D (cholecalciferol), 2000 IU per day 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]) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All participants in VITAL (NCT 01169259) are eligible to participate in this ancillary study.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Omega-3 fatty acids (fish oil)Also: Omacor | Drug | Vitamin D + fish oil, Vitamin D placebo + fish oil |
| Vitamin D3Also: cholecalciferol | Dietary supplement | Vitamin D + fish oil, Vitamin D + fish oil placebo |
| Vitamin D3 placebo | Dietary supplement | Vitamin D placebo + fish oil, Vitamin D placebo + fish oil placebo |
| Fish oil placebo | Drug | Vitamin D + fish oil placebo, Vitamin D placebo + fish oil placebo |
Primary outcome
Dry Eye Disease
Time frame: 5 years
Report of a diagnosis of dry eye disease confirmed by medical record review.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Derived from this study: PubMed 35679030Christen WG, Cook NR, Manson JE, Buring JE, Lee IM, Bubes V, Friedenberg G, Dushkes R, Smith D, Schaumberg DA; VITAL Research Group. Efficacy of Marine omega-3 Fatty Acid Supplementation vs Placebo in Reducing Incidence of Dry Eye Disease in Healthy US Adults: A Randomized Clinical Trial. JAMA Ophthalmol. 2022 Jul 1;140(7):707-714. doi: 10.1001/jamaophthalmol.2022.1818.
- Welcome to the 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.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 fatty acids (fish oil) and Vitamin D3 in people with Dry Eye Disease, run by Brigham and Women's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Dry Eye Disease (time frame: 5 years). 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 NCT01880463, which also lists 1 linked publication.
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 30 Jul 2019; AzTrials last refreshed its copy on 7 Nov 2026.