Night Blindness
Conditions
Keywords
Beta Carotene, visual functions, Fundus albipunctatus, Night Blindness
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).
Interventions
DIETARY_SUPPLEMENTalga 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
Sponsors
Sheba Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Electroretinogram responses | Three months |
Secondary
| Measure | Time frame |
|---|---|
| Visual acuity | Three Months |
Countries
Israel
Outcome results
None listed