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Trial record 83 of 163 for:    ISOTRETINOIN

The Effect of the Alga Dunaliella Bardawil as a Source of 9-cis Retinoic Acid on Lipid Profile in Fibrate Treated Patients.

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ClinicalTrials.gov Identifier: NCT00156169
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : August 12, 2009
Sponsor:
Information provided by:
Sheba Medical Center

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 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 b-carotene/day. The all-trans to 9-cis b-carotene ratio in the capsules is about 1:1.


Condition or disease Intervention/treatment Phase
Low HDL Cholesterol Drug: Dunaliella Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Official Title: The Effect of the Alga Dunaliella Bardawil as a Source of 9-cis Retinoic Acid
Study Start Date : May 2001
Actual Study Completion Date : December 2006

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18-70 years
  • Fibrate treatment (for at least 6 weeks)
  • HDL-Cholesterol lower than 40mg/dl.
  • Triglyceride over 150mg/dl.

Exclusion Criteria:

  • High CPK.
  • Elevated liver functions.
  • Active CHD.
  • Smokers.
  • Diabetes patients treated with Insulin or Avandia. HbA1C great than 8.5.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00156169


Sponsors and Collaborators
Sheba Medical Center
Investigators
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Study Director: Ayelet Harari, Phd Sheba Medical Center

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ClinicalTrials.gov Identifier: NCT00156169     History of Changes
Other Study ID Numbers: SHEBA-01-2358-AH-CTIL
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: August 12, 2009
Last Verified: August 2009
Additional relevant MeSH terms:
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Tretinoin
Alitretinoin
Isotretinoin
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents