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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-01

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Retinitis Pigmentosa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Alga vs. placebo

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

Alga Dunaliella Bardawil

Intervention Type DIETARY_SUPPLEMENT

Placebo (starch)

Intervention Type OTHER

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 .

Group Type PLACEBO_COMPARATOR

Alga Dunaliella Bardawil

Intervention Type DIETARY_SUPPLEMENT

Placebo (starch)

Intervention Type OTHER

Interventions

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Alga Dunaliella Bardawil

Intervention Type DIETARY_SUPPLEMENT

Placebo (starch)

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No