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Sponsored by: |
Sheba Medical Center |
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Information provided by: | Sheba Medical Center |
ClinicalTrials.gov Identifier: | NCT00156169 |
The effect of fibrates on high density lipoprotein (HDL)-cholesterol levels is suggested to be mediated by its binding to peroxisome proliferator-activated receptor- (PPAR). Upon ligand binding, PPAR 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 -carotene-rich powder of the alga Dunaliella bardawil, as a source of 9-cis retinoic acid, would improve the drug’s effect on HDL-cholesterol levels.
patients with plasma HDL-cholesterol levels below 40 mg/dl and triglyceride (TG) levels above 200 mg/dl after fibrate treatment (for at least 6 weeks). are given four capsules of Dunaliella, providing 60 mg -carotene/day. The all-trans to 9-cis -carotene ratio in the capsules is about 1:1.
Condition | Intervention | Phase |
---|---|---|
Low HDL Cholesterol |
Drug: Dunaliella |
Phase III |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Placebo Control, Crossover Assignment |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Israel | |
Institute of lipid & Atherosclerosis Research, Sheba Medical Center | Recruiting |
Tel Hashomer, Israel, 52621 | |
Contact: Tamar Luvish, RN 972-3-5302940 | |
Principal Investigator: Dror Harats, Prof' | |
Institute of Lipid & Atherosclerosis Research, Sheba Medical Center | Recruiting |
Tel Hashomer, Israel, 52621 | |
Contact: tamar luvish, coordinator 972-3-5302940 tamar.luvish@sheba.health.gov |
Study Director: | Ayelet Harari, Phd | Sheba Medical Center |
Study ID Numbers: | SHEBA-01-2358-AH-CTIL |
Study First Received: | September 8, 2005 |
Last Updated: | August 29, 2006 |
ClinicalTrials.gov Identifier: | NCT00156169 |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Clofibric Acid Alitretinoin Isotretinoin Tretinoin |