DHA Supplementation in Patients With STGD3 | NCT00420602

Studies
DHA Supplementation in Patients With STGD3

NCT00420602

Sponsor

University of Utah

Status

Completed

Last Update Posted

May 9, 2018Actual

Enrollment

11Actual

Phase

Not Applicable

Conditions

Dominantly Inherited Stargardt's Disease (STGD3)

Interventions

Over the counter DHA/EPA dietary supplementation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 21, 2007Actual

Primary Completion Date

Dec 27, 2017Actual

Completion Date

Dec 27, 2017Actual

First Submitted Date

Jan 10, 2007

First Submission Date that Met QC Criteria

Jan 10, 2007

First Posted Date

Jan 11, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 8, 2018

Last Update Posted Date

May 9, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Arm, Open Label	Other	Single Arm, Open Label	Dietary Supplement: Over the counter DHA/EPA dietary supplementation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Over the counter DHA/EPA dietary supplementation	Dietary Supplement	1000 mg/day DHA/EPA	Single Arm, Open Label

Measure	Description	Time Frame
ERG		1 year

Measure	Description	Time Frame
Visual acuity		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All Moran Eye Center patients with STGD3

Exclusion Criteria:

All others

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

105 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paul S. Bernstein, MD Ph.D.	University of Utah	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Moran Eye Center, University of Utah		Salt Lake City	Utah	84132	United States