Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00569023
Recruitment Status : Completed
First Posted : December 6, 2007
Last Update Posted : June 28, 2012
Information provided by (Responsible Party):
Dr. Ygal Rotenstreich, Sheba Medical Center

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Night Blindness Dietary Supplement: alga Dunaliella bardawil Not Applicable

Layout table for study information
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

Primary Outcome Measures :
  1. Electroretinogram responses [ Time Frame: Three months ]

Secondary Outcome Measures :
  1. Visual acuity [ Time Frame: Three Months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
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
  • Diagnosed with Fundus albipunctatus

    1. Isolated rod response markedly reduced (less than 20% of normal)after 20 minutes dark adaptation and improved by 50% after 2 hours
    2. Negative maximal response (a wave to b wave ratio less than 2)
    3. 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00569023

Layout table for location information
Sheba Medical Center
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Layout table for investigator information
Principal Investigator: Ygal Rotenstreich, MD Sheba Medical Center
Layout table for additonal information
Responsible Party: Dr. Ygal Rotenstreich, Opthalmologist, Sheba Medical Center 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
Keywords provided by Dr. Ygal Rotenstreich, Sheba Medical Center:
Beta Carotene
visual functions
Fundus albipunctatus
Night Blindness
Additional relevant MeSH terms:
Layout table for MeSH terms
Night Blindness
Vitamin A Deficiency
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Deficiency Diseases
Nutrition Disorders