[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100184751":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":24,"locations":34,"responsibleParty":46,"collaborators":24,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":24,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":24,"enrollmentInfo":58,"targetDuration":24,"studyType":61,"phases":62,"briefSummary":65,"conditions":66,"keywords":24,"overallStatus":68,"whyStopped":24,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Sheba Medical Center","OTHER_GOV",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Alga Dunaliella Bardawil 9-cis beta Carotene Rich Powder","EXPERIMENTAL","50 patients will receive first the capsules containing the alga Dunaliella Bardawil 9-cis beta-Carotene rich powder and after 24 weeks of washout period will receive capsule containing placebo (Starch).",[13,14],"Dietary Supplement: Alga Dunaliella Bardawil","Other: Placebo (starch)",{"label":16,"type":17,"description":18,"interventionNames":19},"Placebo (Starch)","PLACEBO_COMPARATOR","The other 50 Patients will receive first the placebo (Starch) capsules and after 24 weeks of washout period will receive capsules containing the alga Dunaliella Bardawil 9-cis beta-Carotene rich powder .",[13,14],[21,26],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":24},"DIETARY_SUPPLEMENT","Alga Dunaliella Bardawil",null,[9,16],{"type":27,"name":28,"description":24,"armGroupLabels":29,"otherNames":24},"OTHER","Placebo (starch)",[9,16],[31],{"name":32,"affiliation":5,"role":33},"Ygal Rotenstreich, Dr.","PRINCIPAL_INVESTIGATOR",[35],{"facility":5,"status":24,"city":36,"state":24,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":24},"Tel Litwinsky","52621","Israel","IL",{"type":41,"coordinates":42},"Point",[43,44],34.84588,32.05096,{"lat":44,"lon":43},{"type":33,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Dr. Ygal Rotenstreich","Director of Hereditary Retinal Diseases and Electrophysiology Clinic","100184751","phase-1-the-effect-of-oral-administration-of-9-cis--carotene-rich-powder-of-the-alga-dunaliella-bardawil-100184751",false,"NCT01680510","The Effect of Oral Administration of 9-cis β Carotene Rich Powder of the Alga Dunaliella Bardawil","The Effect of Oral Administration of 9-cis β Carotene Rich Powder of the Alga Dunaliella Bardawil on Visual Functions in Patients With Retinitis Pigmentosa","Inclusion Criteria:\n\n* Written informed consent to participate in the study.\n* Men or women aged 18 years or older.\n* Electroretinogram (ERG) responses compatible with the diagnosis of Retinitis Pigmentosa\n\nExclusion Criteria:\n\n* Current smokers.\n* Current use of Vitamin A\u002F beta carotene supplements.\n* 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.\n* History of malignancy, except basal or squamous cell skin carcinoma.\n* Pregnant women, women who are breast feeding, and women of childbearing potential who are not using chemical or mechanical contraception.\n* 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.\n* History of alcohol abuse or drug abuse, or both.\n* Patient plans to engage in vigorous exercise or an aggressive diet regimen.\n* Uncontrolled endocrine or metabolic disease.\n* Participation in another investigational drug study within 4 weeks of entry into this study.\n* 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.\n* Subject whose hormone replacement therapy (HRT) or oral contraceptive therapy (OCT) was initiated within the 3 month prior to enrollment.","ALL","18 Years",{"count":59,"type":60},100,"ESTIMATED","INTERVENTIONAL",[63,64],"PHASE1","PHASE2","Retinitis pigmentosa is a genetically disease consisting of progressive retinal degeneration starting in the rods. Its prevalence is 1:4000 people and is the fourth most common blinding disease in Israel in 2004 \\[7% of all blindness\\]. The investigators treated 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.\n\nThe 9-cis β -carotene has been shown to be a precursor of 9-cis retinoic acid both in-vitro in human intestinal mucosa and in-vivo in a ferret, perfused with 9-cis b-carotene. The night vision, as measured objectively by electroretinography (ERG) more than doubled in six patients tested following treatment. The visual field was also improved significantly. In a more recent study the investigators treated 29 retinitis pigmentosa patients with the 9-cis b Carotene algae Dunaliella Bardawil in a double masked placebo control cross over trial. Significant improvement in retinal function was recorded in 34% of the patients.",[67],"Retinitis Pigmentosa","UNKNOWN","2024-04-24",{"date":71,"type":72},"2024-04-25","ACTUAL",{"date":74,"type":72},"2012-09-01",{"date":76,"type":60},"2025-12-31",{"name":5,"class":6},1]