Nctid:
NCT00001242
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-16"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000012279", "term"=>"Rickets"}, {"id"=>"D000010018", "term"=>"Osteomalacia"}, {"id"=>"D000011547", "term"=>"Pseudohypoparathyroidism"}, {"id"=>"D000011556", "term"=>"Pseudopseudohypoparathyroidism"}, {"id"=>"D000006996", "term"=>"Hypocalcemia"}], "ancestors"=>[{"id"=>"D000002128", "term"=>"Calcium Metabolism Disorders"}, {"id"=>"D000008659", "term"=>"Metabolic Diseases"}, {"id"=>"D000014883", "term"=>"Water-Electrolyte Imbalance"}, {"id"=>"D000001851", "term"=>"Bone Diseases, Metabolic"}, {"id"=>"D000001847", "term"=>"Bone Diseases"}, {"id"=>"D000009140", "term"=>"Musculoskeletal Diseases"}, {"id"=>"D000014808", "term"=>"Vitamin D Deficiency"}, {"id"=>"D000001361", "term"=>"Avitaminosis"}, {"id"=>"D000003677", "term"=>"Deficiency Diseases"}, {"id"=>"D000044342", "term"=>"Malnutrition"}, {"id"=>"D000009748", "term"=>"Nutrition Disorders"}, {"id"=>"D000008664", "term"=>"Metal Metabolism, Inborn Errors"}, {"id"=>"D000008661", "term"=>"Metabolism, Inborn Errors"}, {"id"=>"D000030342", "term"=>"Genetic Diseases, Inborn"}], "browseLeaves"=>[{"id"=>"M15108", "name"=>"Rickets", "asFound"=>"Rickets", "relevance"=>"HIGH"}, {"id"=>"M10046", "name"=>"Hypocalcemia", "asFound"=>"Hypocalcemia", "relevance"=>"HIGH"}, {"id"=>"M14404", "name"=>"Pseudohypoparathyroidism", "asFound"=>"Pseudohypoparathyroidism", "relevance"=>"HIGH"}, {"id"=>"M14413", "name"=>"Pseudopseudohypoparathyroidism", "asFound"=>"Pseudohypoparathyroidism", "relevance"=>"HIGH"}, {"id"=>"M12941", "name"=>"Osteomalacia", "asFound"=>"Osteomalacia", "relevance"=>"HIGH"}, {"id"=>"M14403", "name"=>"Pseudohypoaldosteronism", "relevance"=>"LOW"}, {"id"=>"M11639", "name"=>"Metabolic Diseases", "relevance"=>"LOW"}, {"id"=>"M5391", "name"=>"Calcium Metabolism Disorders", "relevance"=>"LOW"}, {"id"=>"M17624", "name"=>"Water-Electrolyte Imbalance", "relevance"=>"LOW"}, {"id"=>"M5126", "name"=>"Bone Diseases", "relevance"=>"LOW"}, {"id"=>"M5130", "name"=>"Bone Diseases, Metabolic", "relevance"=>"LOW"}, {"id"=>"M12097", "name"=>"Musculoskeletal Diseases", "relevance"=>"LOW"}, {"id"=>"M17551", "name"=>"Vitamin D Deficiency", "relevance"=>"LOW"}, {"id"=>"M4660", "name"=>"Avitaminosis", "relevance"=>"LOW"}, {"id"=>"M6879", "name"=>"Deficiency Diseases", "relevance"=>"LOW"}, {"id"=>"M25306", "name"=>"Malnutrition", "relevance"=>"LOW"}, {"id"=>"M12684", "name"=>"Nutrition Disorders", "relevance"=>"LOW"}, {"id"=>"M11641", "name"=>"Metabolism, Inborn Errors", "relevance"=>"LOW"}, {"id"=>"M11644", "name"=>"Metal Metabolism, Inborn Errors", "relevance"=>"LOW"}, {"id"=>"M23686", "name"=>"Genetic Diseases, Inborn", "relevance"=>"LOW"}, {"id"=>"T5019", "name"=>"Rickets", "asFound"=>"Rickets", "relevance"=>"HIGH"}, {"id"=>"T4783", "name"=>"Pseudohypoparathyroidism", "asFound"=>"Pseudohypoparathyroidism", "relevance"=>"HIGH"}, {"id"=>"T4796", "name"=>"Pseudopseudohypoparathyroidism", "asFound"=>"Pseudohypoparathyroidism", "relevance"=>"HIGH"}, {"id"=>"T4319", "name"=>"Osteomalacia", "asFound"=>"Osteomalacia", "relevance"=>"HIGH"}, {"id"=>"T267", "name"=>"Albright's Hereditary Osteodystrophy", "relevance"=>"LOW"}, {"id"=>"T4784", "name"=>"Pseudohypoparathyroidism Type 1A", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Musculoskeletal Diseases", "abbrev"=>"BC05"}, {"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Diseases and Abnormalities at or Before Birth", "abbrev"=>"BC16"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M17550", "name"=>"Vitamin D", "relevance"=>"LOW"}, {"id"=>"M6003", "name"=>"Cholecalciferol", "relevance"=>"LOW"}, {"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}, {"id"=>"M17558", "name"=>"Vitamins", "relevance"=>"LOW"}, {"id"=>"M13194", "name"=>"Parathyroid Hormone", "relevance"=>"LOW"}, {"id"=>"T442", "name"=>"Cholecalciferol", "relevance"=>"LOW"}, {"id"=>"T479", "name"=>"Vitamin D3", "relevance"=>"LOW"}, {"id"=>"T440", "name"=>"Calciferol", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Bone Density Conservation Agents", "abbrev"=>"BDCA"}, {"name"=>"Micronutrients", "abbrev"=>"Micro"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Vitamins", "abbrev"=>"Vi"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>70}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1997-08-12", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2023-01", "completionDateStruct"=>{"date"=>"2022-12-12", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2023-01-19", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"1999-11-03", "lastUpdatePostDateStruct"=>{"date"=>"2023-01-20", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"1999-11-04", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"2022-12-12", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"This study will provide information about problems relating to calcium in the blood, urine, and bones", "timeFrame"=>"take one to two weeks", "description"=>"This is a natural history protocol, directed at diagnosing and managing the general clinical features in these patients. In addition the full clinical expression of certain rare disorders (target resistance to 1,25(OH)2D, pseudohypoparathyroidism, and pseudo- pseudohypoparathyroidism) will be characterized further. Some of these patients or their relatives will be entered into additional protocols, where appropriate for example, protocols to characterize the molecular causes of these disorders."}]}, "conditionsModule"=>{"keywords"=>["Rickets", "Hypocalcemia", "Albright Hereditary Osteodystrophy", "Pseudohypoaldosteronism", "Natural History"], "conditions"=>["Hypocalcemia", "Pseudohypoparathyroidism", "Osteomalacia", "Rickets", "Pseudopseudohpoparathyroidism"]}, "referencesModule"=>{"references"=>[{"pmid"=>"6893458", "type"=>"BACKGROUND", "citation"=>"Marx SJ, Swart EG Jr, Hamstra AJ, DeLuca HF. Normal intrauterine development of the fetus of a woman receiving extraordinarily high doses of 1,25-dihydroxyvitamin D3. J Clin Endocrinol Metab. 1980 Nov;51(5):1138-42. doi: 10.1210/jcem-51-5-1138."}, {"pmid"=>"1862138", "type"=>"BACKGROUND", "citation"=>"Nemeth AJ, Eaglstein WH, Falanga V, Hevia O, Taylor JR. Methods to speed healing after skin biopsy or trichloroacetic acid chemical peel. Prog Clin Biol Res. 1991;365:267-77. No abstract available."}], "seeAlsoLinks"=>[{"url"=>"https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_1989-DK-0173.html", "label"=>"NIH Clinical Center Detailed Web Page"}]}, "descriptionModule"=>{"briefSummary"=>"Patients with confirmed or suspected states with resistance to vitamin D or parathyroid hormone (PTH) will be admitted for diagnosis, treatment review with suggestions for modifications to the current or new treatment and for inclusion in other protocols. These states include hypocalcemia, rickets, osteomalacia, pseudohypoparathyroidism. Resistance to a factor is manifested by deficient bioeffect despite high levels of the factor in blood. Patients will be tested with multiple indices of mineral metabolism to establish the diagnosis and examine the spectrum of the underlying disorder. The principal therapies will be combinations of calcium, phosphate, and a vitamin D analog. Selected patients will have localization and surgery to remove a tumor that causes renal wasting of phosphate. Patients will also be considered for entry into other research protocols.", "detailedDescription"=>"Patients with confirmed or suspected states with resistance to vitamin D or parathyroid hormone (PTH) will be admitted for diagnosis, treatment review with suggestions for modifications to the current or new treatment and for inclusion in other protocols. These states include hypocalcemia, rickets, osteomalacia, pseudohypoparathyroidism. Resistance to a factor is manifested by deficient bioeffect despite high levels of the factor in blood. Patients will be tested with multiple indices of mineral metabolism to establish the diagnosis and examine the spectrum of the underlying disorder. The principal therapies will be combinations of calcium, phosphate, and a vitamin D analog. Selected patients will have localization and surgery to remove a tumor that causes renal wasting of phosphate. Patients will also be considered for entry into other research protocols."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "maximumAge"=>"100 years", "minimumAge"=>"2 months", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patients with confirmed or suspected states with resistance to vitamin D or parathyroid hormone (PTH)", "healthyVolunteers"=>false, "eligibilityCriteria"=>"* INCLUSION CRITERIA:\n\nPatients, from 2 months to 100 years of age, of either sex M or F, with vitamin D resistance, rickets, osteomalacia, pseudohypoparathyroidism, pseudo-pseudohypoparathyroidism, or suspicion of these or related disorders based upon the appropriateness of their problem to ongoing investigations.\n\nCurrent investigations are focused principally upon the inclusion of subjects with, or suspected of having, hypocalcemia likely due to a resistance to parathyroid hormone, including subjects who have a diagnosis, or likely diagnosis, of pseudohypoparathyroidism or pseudopseudohypoparathyroidism."}, "identificationModule"=>{"nctId"=>"NCT00001242", "briefTitle"=>"Studies of States With Resistance to Vitamin D and Parathyroid Hormone", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"Studies of States With Resistance to Vitamin D and Parathyroid Hormone", "orgStudyIdInfo"=>{"id"=>"890173"}, "secondaryIdInfos"=>[{"id"=>"89-DK-0173"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Study Cohort", "description"=>"Patients of any age or sex with vitamin D resistance, rickets, osteomalacia, pseudohypoparathyroidism, pseudo- pseudohypoparathyroidism, or suspicion of these or related disorders"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "country"=>"United States", "facility"=>"National Institutes of Health Clinical Center", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}], "overallOfficials"=>[{"name"=>"Lee S Weinstein, M.D.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
