NCT01256697

The Effect of Oral Administration of 9-cis Rich Powder of the Alga Dunaliella Bardawil on Visual Functions im Patients With Retinitis Pigmentosa

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Sheba Medical Center · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Retinitis pigmentosa is a genetically determined disease consisting of progressive centripetal retinal degeneration starting in the rods outer segments. Its prevalence is 1:4000 people and is the fourth most common blinding disease in Israel in 2004 \[7% of all blindness\]. The investigators tried to treat 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 shown to be a precursor of 9-cis retinoic acid both in-vitro in human intestinal mucosa and in-vivo in a ferret, perfuse with 9-cis b-carotene. The night vision, as measured objectively by electroretinography (ERG) more than doubled in six patients tested. The visual field was also improved significantly.

Conditions

• Retinitis Pigmentosa

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Alga Dunaliella Bardawil	9-cis Rich Powder
DIETARY_SUPPLEMENT	Alga Dunaliella Bardawill	9-cis Rich Powder
OTHER	Sugar pill	Sugar pill

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-04-01
• Completion: 2011-01-01
• First posted: 2010-12-08
• Last updated: 2013-12-20

Locations

1 site across 1 country: Israel