Treatment of Congenital Stationary Night Blindness With an Alga Containing High Dose of Beta Carotene

Study Overview
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Brief Summary
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To assess the effect of oral administration of the alga Dunaliella bardawil containing approximately 50% all-trans beta-carotene and 50% 9-cis beta-carotene isomers on visual functions patients with Congenital Stationary Night Blindness {Fundus albipunctatus).

Official Title
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Treatment of Congenital Stationary Night Blindness With an Alga Containing High Dose of Beta Carotene

Conditions
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Night Blindness

Intervention / Treatment
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* Dietary Supplement: alga Dunaliella bardawil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent to participate in the study. Men or women aged 18 years or older Diagnosed with Fundus albipunctatus Isolated rod response markedly reduced (less than 20% of normal)after 20 minutes dark adaptation and improved by 50% after 2 hours Negative maximal response (a wave to b wave ratio less than 2) Retinal midperipheral white dots (More than 3000 dots) 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. Active liver disease or hepatic dysfunction as defined by elevations of 2.0 times the ULN in any of the following liver function tests: ALT, AST or bilirubin. Serum CPK > 2.0 times ULN in visit 0 TSH above the normal range. Newly diagnosed diabetes within 3 months. 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. Serum creatinine > 2.0 mg/dl before the treatment phase, +3 proteinuria in urine dipstick, or a history of renal transplantation before the treatment period. Subject whose hormone replacement therapy (HRT) or oral contraceptive therapy (OCT) was initiated within the 3 month prior to enrollment. Forbidden medications: the combination of PPAR alpha agonists-fibric acid derivatives, PPAR gamma agonists.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A,1,I<br> | Dietary Supplement: alga Dunaliella bardawil<br>* Each patients will be treated with four capsules daily of Dunaliella bardawil for 90 days. Alga Dunaliella bardawil containing 15 mg approximately 50% all-trans beta-carotene and 50% 9-cis beta-carotene isomers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electroretinogram responses |  | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  | Three Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Beta Carotene, visual functions, Fundus albipunctatus, Night Blindness