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

Plain-language summary

This study examines the effect of an alga called Dunaliella Bardawil, a source of 9-cis retinoic acid, on blood lipid levels in patients taking a fibrate drug. It enrolled patients aged 18 to 70 who had been on fibrate treatment for at least 6 weeks and had low HDL cholesterol and high triglyceride levels. The research was conducted in Phase 3 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 3

Status

Completed

Sponsor

Sheba Medical Center

Intervention

Dunaliella

Start date

5/1/2001

Estimated completion

12/1/2006

Related genes

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.