The Effect of Oral Administration of 9-cis Rich Powder of the Alga Dunaliella
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Electroretinogram scotopic maxiamal b-wave amplitude responses in microvolts
研究概览
简要总结
Retinitis pigmentosa is a genetically determined disease consisting of progressive centripetal retinal degeneration starting in the rods outer segments. Its prevalence is 1:4000 people and is the fourth most common blinding disease in Israel in 2004 [7% of all blindness]. The investigators tried to treat a non-progressive form of the disease [Fundus Albipunctatus] by oral therapy of the food supplement made from alga Dunaliella bardawil composed of approximately 50% 9-cis β-carotene. The alga Dunaliella bardawil accumulates high concentration of β -carotene when grown under appropriate conditions. The β -carotene of the alga is composed of approximately 50% of all-trans - β carotene and 50% 9-cis β -carotene.
The 9-cis β -carotene has shown to be a precursor of 9-cis retinoic acid both in-vitro in human intestinal mucosa and in-vivo in a ferret, perfuse with 9-cis b-carotene. The night vision, as measured objectively by electroretinography (ERG) more than doubled in six patients tested. The visual field was also improved significantly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 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.
- •Electroretinogram (ERG) responses compatible with the diagnosis of Retinitis Pigmentosa
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.
- •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.
- •Subject whose hormone replacement therapy (HRT) or oral contraceptive therapy (OCT) was initiated within the 3 month prior to enrollment.
结局指标
主要结局
Electroretinogram scotopic maxiamal b-wave amplitude responses in microvolts
时间窗: 1 year
Using the protocol of the International Society for Clinical Electrophysiology of Vision and the UTAS 3000 system (LKC Technologies, Gaithersburg, MD), we recorded full-field electroretinographic responses from both eyes of each patient. The scotopic conditions, after 30 minutes of dark adaptation we recorded the maximal scotopic response. The b-wave amplitude responses will be messured in each eye.
次要结局
- The area within the Dark adapted chromatic Goldamann Visual field in isopters in cm2(1 year)
研究者
Dr. Ygal Rotenstreich
Ophthalmologist
Sheba Medical Center