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

This study is currently recruiting participants.
Verified May 2013 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Dr. Ygal Rotenstreich, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01680510
First received: September 4, 2012
Last updated: May 21, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention Phase
Retinitis Pigmentosa
 Dietary Supplement: Alga Dunaliella Bardawil
Other: Sugar pill
 Phase 3

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 50
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)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01680510

Locations
Israel
Sheba Medical Center Recruiting
Ramat Gan, Israel, 52621
Contact: Ygal Rotenstreich, Dr.     972-3-5302880        
Principal Investigator: Ygal Rotenstreich, Dr.            
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Ygal Rotenstreich, Dr. Sheba Medical Center
  More Information

No publications provided

Responsible Party: Dr. Ygal Rotenstreich, Director of Hereditary Retinal Diseases and Electrophysiology Clinic, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01680510     History of Changes
Other Study ID Numbers: SHEBA-12-9373-YR-CTIL
Study First Received: September 4, 2012
Last Updated: May 21, 2013
Health Authority: Israel: Ethics Commission
Israel: Israeli Health Ministry Pharmaceutical Administration
Israel: Ministry of Health
Israel: The Israel National Institute for Health Policy Research and Health Services Research

Additional relevant MeSH terms:
Retinitis
Retinitis Pigmentosa
Retinal Diseases
Eye Diseases
 Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on May 23, 2013