Age-related Macular DegenerationNCT01782352
Age-related Macular Degeneration (AMD) in the Vitamin D and Omega-3 Trial (VITAL)
A study testing Omega-3 fatty acids (fish oil) and Vitamin D3 in people with Age-related Macular Degeneration, 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 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
- Age-related Macular Degeneration
- 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
- 25,871 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02215
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 vitamin D or omega-3 fatty acids, compared to placebo, reduce the incidence and/or progression of age-related macular degeneration (AMD).
Read the detailed description
This ancillary study to the VITamin D and OmegA-3 TriaL (VITAL) will examine whether vitamin D3 and omega-3 fatty acids can help prevent the onset or progression of age-related macular degeneration (AMD). The study will also examine whether vitamin D3 and omega-3 fatty acids interact with each other, or with specific genes associated with AMD or vitamin D3 or omega-3 fatty acid metabolic activity, to affect the risk of developing AMD.
- Conditions
- Age-related Macular Degeneration
- Being tested
- Omega-3 fatty acids (fish oil), Vitamin D3, Vitamin D3 placebo, Fish oil placebo
- Keywords
- age-related macular degeneration, incidence, progression
- Medical subject headings
- Macular Degeneration, 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 placeboDietary supplement
| 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; Dietary Supplement: 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; Dietary Supplement: 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.
Number of Participants With an AMD Event
AMD Event = a composite endpoint of incident AMD plus cases of progression to advanced AMD among participants with AMD at baseline
Measured: 5 years
Secondary outcomes (2)
Number of Participants With Incident Visually-Significant AMD
AMD responsible for a reduction in best-corrected visual acuity to 20/30 or worse
Measured: 5 years
Number of Participants With Incident Advanced AMD
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 Feb 2013 (estimated)
- Study startJul 2010
- Primary completionDec 2019
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Age-related Macular DegenerationStudies 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
- 25,871 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, William G. Christen, Brigham and Women's Hospital
- Investigators
- Debra A Schaumberg, ScD, Principal investigator, Brigham and Women's HospitalWilliam G Christen, ScD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01782352
- Sponsor's protocol ID
- 2012P001797
- Other IDs
- R01EY021900, 2012P000724
- Status last verified
- Jul 2023
- First submitted
- 31 Jan 2013
- Last updated
- 8 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Christen WG, Cook NR, Manson JE, Buring JE, Chasman DI, Lee IM, Bubes V, Li C, Haubourg M, Schaumberg DA; VITAL Research Group. Effect of Vitamin D and omega-3 Fatty Acid Supplementation on Risk of Age-Related Macular Degeneration: An Ancillary Study of the VITAL Randomized Clinical Trial. JAMA Ophthalmol. 2020 Dec 1;138(12):1280-1289. doi: 10.1001/jamaophthalmol.2020.4409.
PubMed 33119047
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age-related Macular Degeneration (AMD) in the Vitamin D and Omega-3 Trial (VITAL)
- ClinicalTrials.gov ID
- NCT01782352
- Acronym / sponsor ID
- 2012P001797
- Conditions
- Age-related Macular Degeneration
- Keywords
- age-related macular degeneration, incidence, progression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25,871 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- Jul 2010
- Primary completion
- Dec 2019 (actual)
- Study completion
- Sep 2024 (estimated)
- First posted
- 1 Feb 2013 (estimated)
- Results
- Posted 22 Aug 2022
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 vitamin D or omega-3 fatty acids, compared to placebo, reduce the incidence and/or progression of age-related macular degeneration (AMD).
Detailed description
This ancillary study to the VITamin D and OmegA-3 TriaL (VITAL) will examine whether vitamin D3 and omega-3 fatty acids can help prevent the onset or progression of age-related macular degeneration (AMD). The study will also examine whether vitamin D3 and omega-3 fatty acids interact with each other, or with specific genes associated with AMD or vitamin D3 or omega-3 fatty acid metabolic activity, to affect the risk of developing AMD.
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, Dietary Supplement: 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, Dietary Supplement: 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 | Dietary supplement | Vitamin D + fish oil placebo, Vitamin D placebo + fish oil placebo |
Primary outcome
Number of Participants With an AMD Event
Time frame: 5 years
AMD Event = a composite endpoint of incident AMD plus cases of progression to advanced AMD among participants with AMD at baseline
2 secondary outcomes
Number of Participants With Incident Visually-Significant AMD
Time frame: 5 years
Number of Participants With Incident Advanced AMD
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33119047Christen WG, Cook NR, Manson JE, Buring JE, Chasman DI, Lee IM, Bubes V, Li C, Haubourg M, Schaumberg DA; VITAL Research Group. Effect of Vitamin D and omega-3 Fatty Acid Supplementation on Risk of Age-Related Macular Degeneration: An Ancillary Study of the VITAL Randomized Clinical Trial. JAMA Ophthalmol. 2020 Dec 1;138(12):1280-1289. doi: 10.1001/jamaophthalmol.2020.4409.
- 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.
Debra A Schaumberg, ScD principal investigator
Brigham and Women's Hospital
William G Christen, ScD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
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 Age-related Macular Degeneration, 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?
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 8 Aug 2023. 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?
Yes. Results are posted in the registry (first posted 22 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With an AMD Event (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 NCT01782352, 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 8 Aug 2023.