Treatment of Congenital Stationary Night Blindness With an Alga Containing High Dose of Beta Carotene
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ClinicalTrials.gov Identifier: NCT00569023 |
Recruitment Status :
Completed
First Posted : December 6, 2007
Last Update Posted : June 28, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Night Blindness | Dietary Supplement: alga Dunaliella bardawil | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 7 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Treatment of Congenital Stationary Night Blindness With an Alga Containing High Dose of Beta Carotene |
Study Start Date : | July 2007 |
Actual Primary Completion Date : | August 2009 |
Actual Study Completion Date : | July 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: A,1,I |
Dietary Supplement: alga Dunaliella bardawil
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 |
- Electroretinogram responses [ Time Frame: Three months ]
- Visual acuity [ Time Frame: Three Months ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Written informed consent to participate in the study.
- Men or women aged 18 years or older
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00569023
Israel | |
Sheba Medical Center | |
Tel Hashomer, Israel, 52621 |
Principal Investigator: | Ygal Rotenstreich, MD | Sheba Medical Center |
Responsible Party: | Dr. Ygal Rotenstreich, Opthalmologist, Sheba Medical Center |
ClinicalTrials.gov Identifier: | NCT00569023 |
Other Study ID Numbers: |
SHEBA-06-4496-YR-CTIL |
First Posted: | December 6, 2007 Key Record Dates |
Last Update Posted: | June 28, 2012 |
Last Verified: | June 2012 |
Beta Carotene visual functions Fundus albipunctatus Night Blindness |
Blindness Night Blindness Vitamin A Deficiency Vision Disorders Sensation Disorders Neurologic Manifestations |
Nervous System Diseases Eye Diseases Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders |