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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Ygal Rotenstreich, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00569023
First received: December 5, 2007
Last updated: June 26, 2012
Last verified: June 2012
  Purpose

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 Intervention
Night Blindness
Dietary Supplement: alga Dunaliella bardawil

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Congenital Stationary Night Blindness With an Alga Containing High Dose of Beta Carotene

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Electroretinogram responses [ Time Frame: Three months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Visual acuity [ Time Frame: Three Months ] [ Designated as safety issue: Yes ]

Enrollment: 7
Study Start Date: July 2007
Study Completion Date: July 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569023

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

No publications provided

Responsible Party: Dr. Ygal Rotenstreich, Opthalmologist, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00569023     History of Changes
Other Study ID Numbers: SHEBA-06-4496-YR-CTIL
Study First Received: December 5, 2007
Last Updated: June 26, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
Beta Carotene
visual functions
Fundus albipunctatus
Night Blindness

Additional relevant MeSH terms:
Night Blindness
Vitamin A Deficiency
Myopia
Blindness
Vision Disorders
Eye Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Refractive Errors
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Carotenoids
Beta Carotene
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 22, 2014