RP Cure Tracker

Trials / NCT01680510

The Effect of Oral Administration of 9-cis β Carotene Rich Powder of the Alga Dunaliella Bardawil

Status unknown Phase 1 / Phase 2 Supplement / diet, Drug / neuroprotection

Sponsor
Sheba Medical Center
Treatment
Alga Dunaliella Bardawil; Placebo (starch)
Gene
Not stated
Conditions
Retinitis Pigmentosa
Ages
18 Years to no upper limit
Enrollment
100 participants
Started
2012-09-01
Main results expected
2025-12-31
Results posted
Not yet
Record last updated
2024-04-25

What the study is testing

Retinitis pigmentosa is a genetically disease consisting of progressive retinal degeneration starting in the rods. Its prevalence is 1:4000 people and is the fourth most common blinding disease in Israel in 2004 [7% of all blindness]. The investigators treated a non-progressive form of the disease [Fundus Albipunctatus] by oral therapy of the food supplement made from alga Dunaliella Bardawil composed of approximately 50% 9-cis β-carotene. The alga Dunaliella Bardawil accumulates high concentration of β -carotene when grown under appropriate conditions. The β -carotene of the alga is composed of approximately 50% of all-trans - β carotene and 50% 9-cis β -carotene.

The 9-cis β -carotene has been shown to be a precursor of 9-cis retinoic acid both in-vitro in human intestinal mucosa and in-vivo in a ferret, perfused with 9-cis b-carotene. The night vision, as measured objectively by electroretinography (ERG) more than doubled in six patients tested following treatment. The visual field was also improved significantly. In a more recent study the investigators treated 29 retinitis pigmentosa patients with the 9-cis b Carotene algae Dunaliella Bardawil in a double masked placebo control cross over trial. Significant improvement in retinal function was recorded in 34% of the patients.

Where it runs

Israel (1)

Open on ClinicalTrials.gov for contacts and eligibility