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

• ClinicalTrials.gov Identifier: NCT00569023
• Recruitment Status: Completed
• First Posted: December 6, 2007
• Last Update Posted: June 28, 2012
• Sponsor: Sheba Medical Center
• Information provided by (Responsible Party): Dr. Ygal Rotenstreich, Sheba Medical Center

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Electroretinogram responses [ Time Frame: Three months ]

Secondary Outcome Measures :

1. Visual acuity [ Time Frame: Three Months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Israel

Sheba Medical Center

Tel Hashomer, Israel, 52621

Sponsors and Collaborators

Sheba Medical Center

Investigators

• Principal Investigator: Ygal Rotenstreich, MD; Sheba Medical Center

More Information

• 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
• 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:

Blindness; Night Blindness; Vitamin A Deficiency; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders