Dominantly Inherited Stargardt's Disease (STGD3)NCT00420602
DHA Supplementation in Patients With STGD3
A study testing Over the counter DHA/EPA dietary supplementation in people with Dominantly Inherited Stargardt's Disease (STGD3), run by University of Utah at 1 site in United States.
Trial summary
We have found that biomarkers of long-term elevated dietary intake of omega-3 fatty acids such as DHA and EPA are inversely associated with severity of disease phenotype in STGD3 patients. Therefore, the purpose of this study is to follow STGD3 patients as they supplement their diets with DHA/EPA. Read more about this study
- Who is it for?
- Ages 18 to 105 years
- Conditions the study is for
- Dominantly Inherited Stargardt's Disease (STGD3)
- What is being tested?
- Over the counter DHA/EPA dietary supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2007to 27 Dec 2017
- 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 18 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All Moran Eye Center patients with STGD3
Who cannot join
- All others
Trial locations and contacts
1 site in 1 country.
United States1 site
Moran Eye Center, University of Utah
Salt Lake City, Utah, 84132
About this study
Official title: Clinical Interventions Against Stargardt Macular Dystrophy: DHA Supplementation in Patients With STGD3
We have found that biomarkers of long-term elevated dietary intake of omega-3 fatty acids such as DHA and EPA are inversely associated with severity of disease phenotype in STGD3 patients. Therefore, the purpose of this study is to follow STGD3 patients as they supplement their diets with DHA/EPA.
- Being tested
- Over the counter DHA/EPA dietary supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Over the counter DHA/EPA dietary supplementationDietary supplement
1000 mg/day DHA/EPA
| Study group | Role | What they receive |
|---|---|---|
| Single Arm, Open Label | Other | Single Arm, Open Label Receives: Dietary Supplement: Over the counter DHA/EPA dietary supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
ERG
Measured: 1 year
Secondary outcomes (1)
Visual acuity
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2007 (estimated)
- Study start21 Sep 2007
- Primary completion27 Dec 2017
- Study completion27 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dominantly Inherited Stargardt's Disease (STGD3)Studies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul S. Bernstein, University of Utah
- Investigators
- Paul S. Bernstein, MD Ph.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00420602
- Sponsor's protocol ID
- IRB 19676
- Status last verified
- May 2018
- First submitted
- 10 Jan 2007
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Interventions Against Stargardt Macular Dystrophy: DHA Supplementation in Patients With STGD3
- ClinicalTrials.gov ID
- NCT00420602
- Acronym / sponsor ID
- IRB 19676
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 21 Sep 2007 (actual)
- Primary completion
- 27 Dec 2017 (actual)
- Study completion
- 27 Dec 2017 (actual)
- First posted
- 11 Jan 2007 (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.
We have found that biomarkers of long-term elevated dietary intake of omega-3 fatty acids such as DHA and EPA are inversely associated with severity of disease phenotype in STGD3 patients. Therefore, the purpose of this study is to follow STGD3 patients as they supplement their diets with DHA/EPA.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm, Open Label | Other | Dietary Supplement: Over the counter DHA/EPA dietary supplementationSingle Arm, Open Label |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All Moran Eye Center patients with STGD3
Key exclusion criteria (1 listed)
- All others
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 |
|---|---|---|
| Over the counter DHA/EPA dietary supplementation1000 mg/day DHA/EPA | Dietary supplement | Single Arm, Open Label |
Primary outcome
ERG
Time frame: 1 year
1 secondary outcome
Visual acuity
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
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.
Paul S. Bernstein, MD Ph.D. principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Over the counter DHA/EPA dietary supplementation in people with Dominantly Inherited Stargardt's Disease (STGD3), run by University of Utah 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: finished, as of the sponsor's last update on 9 May 2018. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ERG (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2018.