The Effect of Oral Administration of 9-cis Rich Powder of the Alga Dunaliella
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.
Dietary Supplement: Alga Dunaliella Bardawil
Other: Sugar pill
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Effect of Oral Administration on 9-cis Rich Powder of the Alga Dunaliella Bardawil on Visual Functions im Patients With Retinitis|
- Electroretinogram scotopic maxiamal b-wave amplitude responses in microvolts [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Using the protocol of the International Society for Clinical Electrophysiology of Vision and the UTAS 3000 system (LKC Technologies, Gaithersburg, MD), we recorded full-field electroretinographic responses from both eyes of each patient. The scotopic conditions, after 30 minutes of dark adaptation we recorded the maximal scotopic response. The b-wave amplitude responses will be messured in each eye.
- The area within the Dark adapted chromatic Goldamann Visual field in isopters in cm2 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Kinetic visual field for chromatic stimuli will be recorded in both eye after 30 minutes of dark adaptation. Area of vision within the isopter will be measured by software in cm2.
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: Alga Dunaliella Bardawil 9-cis Rich Powder
25 patients will consume the capsule containing the Alga Dunaliella Bardawil 9-cis Rich Powder
|Dietary Supplement: Alga Dunaliella Bardawil|
Placebo Comparator: Sugar pill
25 patients will consume the capsule (pill) containing sugar.
|Other: Sugar pill|
|Sheba Medical Center||Recruiting|
|Ramat Gan, Israel, 52621|
|Contact: Ygal Rotenstreich, Dr. 972-3-5302880|
|Principal Investigator: Ygal Rotenstreich, Dr.|
|Principal Investigator:||Ygal Rotenstreich, Dr.||Sheba Medical Center|