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

Sheba Medical Center

Status

Completed

Conditions

Night Blindness

Treatments

Dietary Supplement: alga Dunaliella bardawil

Study type

Interventional

Funder types

Other

Identifiers

NCT00569023

SHEBA-06-4496-YR-CTIL

Details and patient eligibility

About

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).

Enrollment

7 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.