Randomized Trial of DHA for Retinitis Pigmentosa Patients Receiving Vitamin A

Launched by CAROL WEIGEL DIFRANCO · Sep 23, 1999

Nctid: NCT00000116

Payload: {"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-17"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000012173", "term"=>"Retinitis"}, {"id"=>"D000012174", "term"=>"Retinitis Pigmentosa"}], "ancestors"=>[{"id"=>"D000012164", "term"=>"Retinal Diseases"}, {"id"=>"D000005128", "term"=>"Eye Diseases"}, {"id"=>"D000015785", "term"=>"Eye Diseases, Hereditary"}, {"id"=>"D000058499", "term"=>"Retinal Dystrophies"}, {"id"=>"D000012162", "term"=>"Retinal Degeneration"}, {"id"=>"D000030342", "term"=>"Genetic Diseases, Inborn"}], "browseLeaves"=>[{"id"=>"M15008", "name"=>"Retinitis", "asFound"=>"Retinitis", "relevance"=>"HIGH"}, {"id"=>"M15009", "name"=>"Retinitis Pigmentosa", "asFound"=>"Retinitis Pigmentosa", "relevance"=>"HIGH"}, {"id"=>"M14999", "name"=>"Retinal Diseases", "relevance"=>"LOW"}, {"id"=>"M8271", "name"=>"Eye Diseases", "relevance"=>"LOW"}, {"id"=>"M18339", "name"=>"Eye Diseases, Hereditary", "relevance"=>"LOW"}, {"id"=>"M29107", "name"=>"Retinal Dystrophies", "relevance"=>"LOW"}, {"id"=>"M14997", "name"=>"Retinal Degeneration", "relevance"=>"LOW"}, {"id"=>"M23686", "name"=>"Genetic Diseases, Inborn", "relevance"=>"LOW"}, {"id"=>"T4945", "name"=>"Retinitis Pigmentosa", "asFound"=>"Retinitis Pigmentosa", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Eye Diseases", "abbrev"=>"BC11"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Diseases and Abnormalities at or Before Birth", "abbrev"=>"BC16"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000014801", "term"=>"Vitamin A"}], "ancestors"=>[{"id"=>"D000014815", "term"=>"Vitamins"}, {"id"=>"D000018977", "term"=>"Micronutrients"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}], "browseLeaves"=>[{"id"=>"M17550", "name"=>"Vitamin D", "relevance"=>"LOW"}, {"id"=>"M17558", "name"=>"Vitamins", "relevance"=>"LOW"}, {"id"=>"M17544", "name"=>"Vitamin A", "asFound"=>"Hot", "relevance"=>"HIGH"}, {"id"=>"M302395", "name"=>"Retinol palmitate", "relevance"=>"LOW"}, {"id"=>"M21009", "name"=>"Micronutrients", "relevance"=>"LOW"}, {"id"=>"M16885", "name"=>"Trace Elements", "relevance"=>"LOW"}, {"id"=>"T440", "name"=>"Calciferol", "relevance"=>"LOW"}, {"id"=>"T415", "name"=>"Omega 3 Fatty Acid", "asFound"=>"Phototherapy", "relevance"=>"HIGH"}, {"id"=>"T468", "name"=>"Vitamin A", "asFound"=>"Hot", "relevance"=>"HIGH"}, {"id"=>"T462", "name"=>"Retinol", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Bone Density Conservation Agents", "abbrev"=>"BDCA"}, {"name"=>"Micronutrients", "abbrev"=>"Micro"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"Vitamins", "abbrev"=>"Vi"}, {"name"=>"Other Dietary Supplements", "abbrev"=>"Ot"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"QUADRUPLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR"], "maskingDescription"=>"In this trial neither the participants, nor the clinicians, nor the investigators were aware of treatment group assignment."}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>221}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1996-05", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2023-02", "completionDateStruct"=>{"date"=>"2002-09", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2023-02-22", "studyFirstSubmitDate"=>"1999-09-23", "studyFirstSubmitQcDate"=>"1999-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2023-03-08", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"1999-09-24", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"2002-09", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Change in Humphrey Field Analyzer (HFA) total point score 30-2 program", "timeFrame"=>"Annual percent change per year at each of 4 years of followup", "description"=>"Sum of points in Decibels of total points seen in 30-2 program. Higher scores = better vision/larger visual field"}], "secondaryOutcomes"=>[{"measure"=>"Change in Humphrey Field Analyzer (HFA) total point score 30 -2 plus 30/60-2 programs combined", "timeFrame"=>"Annual percent change per year at each of four years of followup", "description"=>"Sum of points in decibels of total points seen in 30-2 and 30/60-2 programs combined- Higher scores = better vision/ larger visual field"}, {"measure"=>"Change in 30Hz Electroretinogram ( ERG) amplitude", "timeFrame"=>"Annual percent change per year at each of four years of followup", "description"=>"Value in microvolts of response to 30hz ERG. Higher values = greater visual function"}, {"measure"=>"Change in Early Treatment of Diabetic Retinopathy(EDTRS) Visual Acuity", "timeFrame"=>"Change in number of letters read per year at each of four years of followup.", "description"=>"Number of letters read per year. More letters read = better visual acuity"}]}, "oversightModule"=>{"oversightHasDmc"=>true}, "conditionsModule"=>{"conditions"=>["Retinitis Pigmentosa"]}, "referencesModule"=>{"references"=>[{"pmid"=>"8512476", "type"=>"BACKGROUND", "citation"=>"Berson EL, Rosner B, Sandberg MA, Hayes KC, Nicholson BW, Weigel-DiFranco C, Willett W. A randomized trial of vitamin A and vitamin E supplementation for retinitis pigmentosa. Arch Ophthalmol. 1993 Jun;111(6):761-72. doi: 10.1001/archopht.1993.01090060049022."}, {"pmid"=>"15364708", "type"=>"RESULT", "citation"=>"Berson EL, Rosner B, Sandberg MA, Weigel-DiFranco C, Moser A, Brockhurst RJ, Hayes KC, Johnson CA, Anderson EJ, Gaudio AR, Willett WC, Schaefer EJ. Clinical trial of docosahexaenoic acid in patients with retinitis pigmentosa receiving vitamin A treatment. Arch Ophthalmol. 2004 Sep;122(9):1297-305. doi: 10.1001/archopht.122.9.1297."}, {"pmid"=>"15364709", "type"=>"RESULT", "citation"=>"Berson EL, Rosner B, Sandberg MA, Weigel-DiFranco C, Moser A, Brockhurst RJ, Hayes KC, Johnson CA, Anderson EJ, Gaudio AR, Willett WC, Schaefer EJ. Further evaluation of docosahexaenoic acid in patients with retinitis pigmentosa receiving vitamin A treatment: subgroup analyses. Arch Ophthalmol. 2004 Sep;122(9):1306-14. doi: 10.1001/archopht.122.9.1306."}]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this trial is to determine whether a nutritional supplement in addition to vitamin A will slow the course of retinitis pigmentosa.", "detailedDescription"=>"Retinitis pigmentosa (RP) is a group of inherited retinal degenerations with a worldwide prevalence of approximately 1 in 4,000. Patients typically report night blindness and difficulty with midperipheral visual field in adolescence. As the condition progresses, they lose far peripheral visual field. Most patients have reductions in central vision by age 50 to 80 years. Based on electroretinograms (ERGs), the course of the disease can be slowed on average among adults on 15,000 IU/day of vitamin A palmitate. While conducting the trial on the effects of vitamin A on RP, it became apparent that another substance in the diet could be affecting the course of the disease. This prompted the present randomized, controlled trial.\n\nThis study is a randomized, controlled, double-masked trial with a planned duration of 5 years. Patients with the common forms of RP are assigned to either a test or a control group. All receive 15,000 IU/day of vitamin A palmitate in addition to either 1200 mg/d of docosahexaenoic acid or control capsules. Participants will not know the contents of the supplement or the group to which they have been assigned until the end of the trial. The main outcome measurement is the total point score on the Humphrey Field Analyzer (HFA). In addition, computer-averaged 30-Hz cone ERG amplitudes and visual acuity are measured annually."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"55 years", "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\nOcular Criteria:\n\nRetinitis Pigmentosa, typical (non-syndromic) forms Best corrected visual acuity Greater than or equal to (GE )20/100 HFA 30-2 total point score GE 250 dB (decibels) 30 (Hertz) Hz ERG cone amplitude GE 0.68 microvolts\n\nDietary Criteria:\n\nDark fish intake Less than or equal to (LE) five servings per week Dietary omega-3 fatty acid intake LE 0.41 g/d Preformed Vitamin A intake in diet and supplements LE 10,000 IU/d Supplement intake LE 5000 IU/d of Vitamin A and LE 30 IU/d Vitamin E Consumption LE 3 alcoholic beverages per day\n\nMedical and other criteria:\n\nBody Mass Index Less than (LT )40 and weight GE 5th percentile for age, sex, and height Serum retinol level LE 100 mg/dl and serum retinyl ester levels LE 380 nm/L Serum cholesterol level LT 300 mg/dL and serum triglyceride levels LT 400 mg/dL Agree not to know study capsule content\n\nExclusion criteria:\n\nOcular criteria:\n\nNo confounding ocular disease\n\nDietary criteria:\n\nNo intake of cod liver oil or omega-3 capsules\n\nMedical and other criteria:\n\nNot pregnant or planning to become pregnant No clinically significant abnormal result on Complete Blood Count or serum liver function profile No other disease which might affect absorption or metabolism of DHA or Vitamin A"}, "identificationModule"=>{"nctId"=>"NCT00000116", "briefTitle"=>"Randomized Trial of DHA for Retinitis Pigmentosa Patients Receiving Vitamin A", "organization"=>{"class"=>"NIH", "fullName"=>"National Eye Institute (NEI)"}, "officialTitle"=>"Clinical Trial of Docosahexaenoic Acid (DHA) in Patients With Retinitis Pigmentosa Receiving Vitamin A Treatment", "orgStudyIdInfo"=>{"id"=>"NEI-12"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Docosahexaenoic acid + Vitamin A", "description"=>"Participants randomized to this arm received 1200 mg/d docosahexaenoic acid and 15000 IU/d Vitamin A as retinyl palmitate", "interventionNames"=>["Dietary Supplement: Vitamin A", "Dietary Supplement: Docosahexaenoic acid"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Control fatty acid + Vitamin A", "description"=>"Patients randomized to this arm received 500 mg/d of fatty acid with no docosahexaenoic acid and 15000 IU/ Vitamin A as retinyl palmitate", "interventionNames"=>["Dietary Supplement: Vitamin A", "Dietary Supplement: Control fatty acid"]}], "interventions"=>[{"name"=>"Vitamin A", "type"=>"DIETARY_SUPPLEMENT", "description"=>"15000 IU/d as retinyl palmitate", "armGroupLabels"=>["Control fatty acid + Vitamin A", "Docosahexaenoic acid + Vitamin A"]}, {"name"=>"Docosahexaenoic acid", "type"=>"DIETARY_SUPPLEMENT", "description"=>"1200 mg/d", "armGroupLabels"=>["Docosahexaenoic acid + Vitamin A"]}, {"name"=>"Control fatty acid", "type"=>"DIETARY_SUPPLEMENT", "armGroupLabels"=>["Control fatty acid + Vitamin A"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"02114", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Berman-Gund Laboratory for the Study of Retinal Degenerations, Harvard Medical School, Massachusetts Eye and Ear Infirmary", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}], "overallOfficials"=>[{"name"=>"Eliot Berson (Deceased), MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Berman-Gund Laboratory for the Study of Retinal Degenerations, Harvard Medical School"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Carol Weigel DiFranco", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR_INVESTIGATOR", "investigatorTitle"=>"coauthor/program manager", "investigatorFullName"=>"Carol Weigel DiFranco", "investigatorAffiliation"=>"National Eye Institute (NEI)"}}}}