Viewing Study NCT00156169



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Last Modification Date: 2024-10-26 @ 9:15 AM
Study NCT ID: NCT00156169
Status: COMPLETED
Last Update Posted: 2009-08-12
First Post: 2005-09-08

Brief Title: The Effect of the Alga Dunaliella Bardawil as a Source of 9-cis Retinoic Acid on Lipid Profile in Fibrate Treated Patients
Sponsor: Sheba Medical Center
Organization: Sheba Medical Center

Study Overview

Official Title: The Effect of the Alga Dunaliella Bardawil as a Source of 9-cis Retinoic Acid
Status: COMPLETED
Status Verified Date: 2009-08
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: The effect of fibrates on high density lipoprotein HDL-cholesterol levels is suggested to be mediated by its binding to peroxisome proliferator-activated receptor-g PPARg Upon ligand binding PPARg heterodimerizes with the 9-cis retinoic acid receptor RXR and the heterodimer regulates gene expression We assessed the hypothesis that a dual treatment with fibrate plus 9-cis b-carotene-rich powder of the alga Dunaliella bardawil as a source of 9-cis retinoic acid would improve the drugs effect on HDL-cholesterol levels

patients with plasma HDL-cholesterol levels below 40 mgdl and triglyceride TG levels above 200 mgdl after fibrate treatment for at least 6 weeks are given four capsules of Dunaliella providing 60 mg b-caroteneday The all-trans to 9-cis b-carotene ratio in the capsules is about 11
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None