The Effect of Oral Administration of 9-cis Rich Powder of the Alga Dunaliella Bardawil on Visual Functions im Patients With Retinitis Pigmentosa
|ClinicalTrials.gov Identifier: NCT01256697|
Recruitment Status : Completed
First Posted : December 8, 2010
Last Update Posted : December 20, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Retinitis Pigmentosa||Dietary Supplement: Alga Dunaliella Bardawil Dietary Supplement: Alga Dunaliella Bardawill Other: Sugar pill||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of Oral Administration of 9-cis Rich Powder of the Alga Dunaliella|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||January 2011|
|Experimental: Alga Dunaliella Bardawil||
Dietary Supplement: Alga Dunaliella Bardawil
9-cis Rich PowderDietary Supplement: Alga Dunaliella Bardawill
9-cis Rich Powder
|Placebo Comparator: Sugar pill||
Other: Sugar pill
- Electroretinogram scotopic maxiamal b-wave amplitude responses in microvolts [ Time Frame: 1 year ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01256697
|Sheba Medical Center|
|Tel Hashomer, Israel|