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

NCT00569023 | Completed

• 1 other identifier: SHEBA-06-4496-YR-CTIL
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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).

Conditions

Night Blindness

Keywords

Beta Carotene; visual functions; Fundus albipunctatus; Night Blindness

Outcome Measures

Primary Outcomes (1)

• Electroretinogram responses

  Three months

Secondary Outcomes (1)

• Visual acuity

  Three Months

Study Arms (1)

A,1,I

EXPERIMENTAL

Dietary Supplement: alga Dunaliella bardawil

Interventions

alga Dunaliella bardawil DIETARY_SUPPLEMENT

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

A,1,I

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent to participate in the study.
• Men or women aged 18 years or older
• Diagnosed with Fundus albipunctatus
• Isolated rod response markedly reduced (less than 20% of normal)after 20 minutes dark adaptation and improved by 50% after 2 hours
• Negative maximal response (a wave to b wave ratio less than 2)
• Retinal midperipheral white dots (More than 3000 dots)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

MeSH Terms

Conditions

Night Blindness; Fundus Albipunctatus

Condition Hierarchy (Ancestors)

Vision Disorders; Eye Diseases

Study Officials

• Ygal Rotenstreich, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Opthalmologist

Study Record Dates

• First Submitted: December 5, 2007
• First Posted: December 6, 2007
• Study Start: July 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: July 1, 2010
• Last Updated: June 28, 2012

Record last verified: 2012-06

Locations

IL (1)