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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
Sponsor:
Information provided by (Responsible Party):
Dr. Ygal Rotenstreich, Sheba Medical Center

Tracking Information
First Submitted Date  ICMJE December 5, 2007
First Posted Date  ICMJE December 6, 2007
Last Update Posted Date June 28, 2012
Study Start Date  ICMJE July 2007
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2007)
Electroretinogram responses [ Time Frame: Three months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2007)
Visual acuity [ Time Frame: Three Months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Congenital Stationary Night Blindness With an Alga Containing High Dose of Beta Carotene
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Night Blindness
Intervention  ICMJE 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  ICMJE Experimental: A,1,I
Intervention: Dietary Supplement: alga Dunaliella bardawil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 26, 2012)
7
Original Estimated Enrollment  ICMJE
 (submitted: December 5, 2007)
5
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00569023
Other Study ID Numbers  ICMJE SHEBA-06-4496-YR-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Ygal Rotenstreich, Sheba Medical Center
Study Sponsor  ICMJE Sheba Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ygal Rotenstreich, MD Sheba Medical Center
PRS Account Sheba Medical Center
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP