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)
- Sheba Medical Center, Tel HaShomer