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

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).

Study Overview

• Status: Completed
• Conditions: Night Blindness
• Intervention / Treatment: Dietary supplement: alga Dunaliella bardawil

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Hashomer, Israel, 52621
    • Sheba Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Electroretinogram responses	Three months

Secondary Outcome Measures

Outcome Measure	Time Frame
Visual acuity	Three Months

Collaborators and Investigators

• Sponsor: Sheba Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (ACTUAL): August 1, 2009
• Study Completion (ACTUAL): July 1, 2010

Study Registration Dates

• First Submitted: December 5, 2007
• First Submitted That Met QC Criteria: December 5, 2007
• First Posted (ESTIMATE): December 6, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): June 28, 2012
• Last Update Submitted That Met QC Criteria: June 26, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: visual functions; Night Blindness; Beta Carotene; Fundus albipunctatus
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Sensation Disorders; Vision Disorders; Night Blindness; Vitamin A Deficiency; Blindness
• Other Study ID Numbers: SHEBA-06-4496-YR-CTIL