NCT00569023已完成不适用
Treatment of Congenital Stationary Night Blindness With an Alga Containing High Dose of Beta Carotene
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Electroretinogram responses
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
A,1,I
Experimental
干预措施: alga Dunaliella bardawil (Dietary Supplement)
结局指标
主要结局
Electroretinogram responses
时间窗: Three months
次要结局
- Visual acuity(Three Months)
研究者
Dr. Ygal Rotenstreich
Opthalmologist
Sheba Medical Center
研究点 (2)
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