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

Tracking Information

• First Submitted Date: December 5, 2007
• First Posted Date: December 6, 2007
• Last Update Posted Date: June 28, 2012
• Study Start Date: July 2007
• Actual Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 5, 2007): Electroretinogram responses [ Time Frame: Three months ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: December 5, 2007): Visual acuity [ Time Frame: Three Months ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Treatment of Congenital Stationary Night Blindness With an Alga Containing High Dose of Beta Carotene
• Official Title: Treatment of Congenital Stationary Night Blindness With an Alga Containing High Dose of Beta Carotene
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Night Blindness

Intervention

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

Study Arms

Experimental: A,1,I

Intervention: Dietary Supplement: alga Dunaliella bardawil

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 26, 2012): 7
• Original Estimated Enrollment (submitted: December 5, 2007): 5
• Actual Study Completion Date: July 2010
• Actual Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT00569023
• Other Study ID Numbers: SHEBA-06-4496-YR-CTIL
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dr. Ygal Rotenstreich, Sheba Medical Center
• Study Sponsor: Sheba Medical Center
• Collaborators: Not Provided

Investigators

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

• PRS Account: Sheba Medical Center
• Verification Date: June 2012