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

This study is currently recruiting participants.
Verified June 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: June 11, 2013
Last verified: June 2013
  Purpose

Retinitis pigmentosa is a genetically disease consisting of progressive retinal degeneration starting in the rods. Its prevalence is 1:4000 people and is the fourth most common blinding disease in Israel in 2004 [7% of all blindness]. The investigators treated 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 been shown to be a precursor of 9-cis retinoic acid both in-vitro in human intestinal mucosa and in-vivo in a ferret, perfused with 9-cis b-carotene. The night vision, as measured objectively by electroretinography (ERG) more than doubled in six patients tested following treatment. The visual field was also improved significantly. In a more recent study the investigators treated 29 retinitis pigmentosa patients with the 9-cis b Carotene algae Dunaliella Bardawil in a double masked placebo control cross over trial. Significant improvement in retinal function was recorded in 34% of the patients.


Condition Intervention Phase
Retinitis Pigmentosa
Dietary Supplement: Alga Dunaliella Bardawil
Other: Placebo (starch)
Phase 2
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 of 9-cis β Carotene Rich Powder of the Alga Dunaliella Bardawil on Visual Functions in Patients With Retinitis Pigmentosa

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Mean binocular maximal scotopic electroretinogram b-wave response [ Time Frame: At weeks 0, 24,48,72 ] [ Designated as safety issue: No ]
    Using the protocol of the International Society for Clinical Electrophysiology of Vision and the UTAS 3000 system (LKC Technologies, Gaithersburg, MD), full-field electroretinographic responses will be recorded from both eyes of each patient. For scotopic conditions, maximal ERG b-wave responses will be recorded following 30 minutes of dark adaptation.


Secondary Outcome Measures:
  • The area within the Dark adapted chromatic Goldamann Visual field in isopters in cm2 [ Time Frame: at weeks 0, 24, 48, 72 ] [ Designated as safety issue: No ]
    Kinetic visual field for chromatic stimuli will be recorded in both eyes after 30 minutes of dark adaptation. Area of vision within the isopter will be measured by software in cm2.

  • The area within Goldamann Visual field in isopters in cm2 [ Time Frame: at weeks 0, 24, 48, 72 ] [ Designated as safety issue: No ]
    Kinetic visual field will be recorded in both eyes. Area of vision within the isopter will be measured by software in cm2.

  • Mean binocular maximal photopic electroretinogram b-wave response [ Time Frame: Weeks 0, 24, 48, 72 ] [ Designated as safety issue: No ]
    Using the protocol of the International Society for Clinical Electrophysiology of Vision and the UTAS 3000 system (LKC Technologies, Gaithersburg, MD), full-field photopic electroretinographic responses will be recorded from both eyes of each patient.

  • Best-corrected visual acuity (EDTRS) [ Time Frame: Weeks 0, 24, 48, 72 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Objective visual field by chromatic multifocal pupillometer [ Time Frame: Weeks 0, 24,48,72 ] [ Designated as safety issue: No ]
    Objective evaluation of 76 point visual field using a chromatic multifocal pupillometer.


Estimated Enrollment: 100
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 beta Carotene Rich Powder
50 patients will receive first the capsules containing the alga Dunaliella Bardawil 9-cis beta-Carotene rich powder and after 24 weeks of washout period will receive capsule containing placebo (Starch).
Dietary Supplement: Alga Dunaliella Bardawil Other: Placebo (starch)
Placebo Comparator: Placebo (Starch)
The other 50 Patients will receive first the placebo (Starch) capsules and after 24 weeks of washout period will receive capsules containing the alga Dunaliella Bardawil 9-cis beta-Carotene rich powder .
Dietary Supplement: Alga Dunaliella Bardawil Other: Placebo (starch)

  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
Tel Hashomer, 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

Publications:
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: June 11, 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
Carotenoids
Beta Carotene
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 15, 2014