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

Primary Purpose

Retinitis Pigmentosa

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Alga Dunaliella Bardawil

Alga Dunaliella Bardawill

Sugar pill

About this trial

This is an interventional treatment trial for Retinitis Pigmentosa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Sheba Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Alga Dunaliella Bardawil

Sugar pill

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01256697

First Posted

February 25, 2010

Last Updated

December 19, 2013

Sponsor

Sheba Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01256697

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

August 2008 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sheba Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Retinitis Pigmentosa

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Alga Dunaliella Bardawil

Arm Type

Experimental

Arm Title

Sugar pill

Arm Type

Placebo Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Alga Dunaliella Bardawil

Intervention Description

9-cis Rich Powder

Intervention Type

Dietary Supplement

Intervention Name(s)

Alga Dunaliella Bardawill

Intervention Description

9-cis Rich Powder

Intervention Type

Other

Intervention Name(s)

Sugar pill

Intervention Description

Sugar pill

Primary Outcome Measure Information:

Title

Electroretinogram scotopic maxiamal b-wave amplitude responses in microvolts

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

The area within the Dark adapted chromatic Goldamann Visual field in isopters in cm2

Description

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.

Time Frame

1 year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Sheba Medical Center

City

Tel Hashomer

Country

Israel

12. IPD Sharing Statement

Citations:

PubMed Identifier

23700011

Citation

Rotenstreich Y, Belkin M, Sadetzki S, Chetrit A, Ferman-Attar G, Sher I, Harari A, Shaish A, Harats D. Treatment with 9-cis beta-carotene-rich powder in patients with retinitis pigmentosa: a randomized crossover trial. JAMA Ophthalmol. 2013 Aug;131(8):985-92. doi: 10.1001/jamaophthalmol.2013.147.

Results Reference

result

PubMed Identifier

32573764

Citation

Schwartz SG, Wang X, Chavis P, Kuriyan AE, Abariga SA. Vitamin A and fish oils for preventing the progression of retinitis pigmentosa. Cochrane Database Syst Rev. 2020 Jun 18;6(6):CD008428. doi: 10.1002/14651858.CD008428.pub3.

Results Reference

derived

Learn more about this trial

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

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