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

Retinitis Pigmentosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01256697
• Other study ID #: SHEBA -08-5086-YR-CTIL
• Status: Completed
• Phase: N/A
• First received: February 25, 2010
• Last updated: December 19, 2013
• Start date: August 2008
• Est. completion date: January 2011

Study information

• Verified date: December 2013
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 2011
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Written informed consent to participate in the study.

• Men or women aged 18 years or older.

• Electroretinogram (ERG) responses compatible with the diagnosis of Retinitis Pigmentosa

Exclusion Criteria:

• Current smokers.

• Current use of Vitamin A/ beta carotene supplements.

• Active arterial disease within 3 months of study entry such as unstable angina, myocardial infarction, transient ischemic attack (TIA), stroke, and coronary artery bypass graft (CABG) surgery.

• History of malignancy, except basal or squamous cell skin carcinoma.

• Pregnant women, women who are breast feeding, and women of childbearing potential who are not using chemical or mechanical contraception.

• Uncontrolled hypertension defined as either resting diastolic blood pressure of >95mmHg (taken from the mean of 3 readings) or resting systolic blood Pressure of > 180 mmHg.

• History of alcohol abuse or drug abuse, or both.

• Patient plans to engage in vigorous exercise or an aggressive diet regimen.

• Uncontrolled endocrine or metabolic disease.

• Participation in another investigational drug study within 4 weeks of entry into this study.

• Serious or unstable medical or psychological condition that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.

• Subject whose hormone replacement therapy (HRT) or oral contraceptive therapy (OCT) was initiated within the 3 month prior to enrollment.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Retinitis
• Retinitis Pigmentosa

Intervention

Dietary Supplement:
• Alga Dunaliella Bardawil
9-cis Rich Powder
• Alga Dunaliella Bardawill
9-cis Rich Powder

Other:
• Sugar pill
Sugar pill

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Rotenstreich Y, Belkin M, Sadetzki S, Chetrit A, Ferman-Attar G, Sher I, Harari A, Shaish A, Harats D. Treatment with 9-cis ß-carotene-rich powder in patients with retinitis pigmentosa: a randomized crossover trial. JAMA Ophthalmol. 2013 Aug;131(8):985-92 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electroretinogram scotopic maxiamal b-wave amplitude responses in microvolts	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.	1 year	Yes
Secondary	The area within the Dark adapted chromatic Goldamann Visual field in isopters in cm2	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.	1 year	Yes