Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004345
Status:
TERMINATED
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Brief Title:
Study of Dietary N-3 Fatty Acids in Patients With Retinitis Pigmentosa and Usher Syndrome
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
None
Status:
TERMINATED
Status Verified Date:
2002-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES I Examine the concentration of docosahexanoic acid DHA and other n-3 fatty acids in plasma erythrocyte and adipose tissue in patients with various forms of retinitis pigmentosa and Usher syndrome
II Determine the synthesis and catabolism of DHA from linolenic acid in these patients
III Determine the synthesis absorption and catabolism of DHA under different dietary conditions in these patients
II Determine the synthesis and catabolism of DHA from linolenic acid in these patients
III Determine the synthesis absorption and catabolism of DHA under different dietary conditions in these patients
Detailed Description:
PROTOCOL OUTLINE Patients may participate in one or more of the arms of this study
Arm I adipose tissue study Adipose tissue is collected from the buttocks of patients with Usher II retinitis pigmentosa RP patients with non-Usher RP and control subjects Dietary histories are obtained from all patients and subjects
Arm II isotope study Patients meeting the same criteria as in arm I receive oral D5-labeled linolenic acid and oral D4-labeled linolenic acid that is dissolved in oil and incorporated into foods Subjects must avoid eating fish and shellfish during the 35 days of the isotope study Blood samples are collected at 0 8 24 and 48 hours daily on days 3-7 and then on days 10 18 and 35
Arm III flaxseed oil feeding Patients with all types of RP and control subjects receive flaxseed oil a form of linolenic acid for 12 weeks Subjects may also receive high oleic safflower oil or olive oil as a control fat for 12 weeks Subjects complete a diet history at the end of each fatty acid supplementation period All subjects must follow a diet free of seafood and fish oil supplements
Arm I adipose tissue study Adipose tissue is collected from the buttocks of patients with Usher II retinitis pigmentosa RP patients with non-Usher RP and control subjects Dietary histories are obtained from all patients and subjects
Arm II isotope study Patients meeting the same criteria as in arm I receive oral D5-labeled linolenic acid and oral D4-labeled linolenic acid that is dissolved in oil and incorporated into foods Subjects must avoid eating fish and shellfish during the 35 days of the isotope study Blood samples are collected at 0 8 24 and 48 hours daily on days 3-7 and then on days 10 18 and 35
Arm III flaxseed oil feeding Patients with all types of RP and control subjects receive flaxseed oil a form of linolenic acid for 12 weeks Subjects may also receive high oleic safflower oil or olive oil as a control fat for 12 weeks Subjects complete a diet history at the end of each fatty acid supplementation period All subjects must follow a diet free of seafood and fish oil supplements
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OHSU-2650 | None | None | None |