Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-02-23 @ 4:31 AM
Study NCT ID:
NCT00535158
Status:
TERMINATED
Last Update Posted:
2017-03-16
First Post:
2007-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin D 2 to Dialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D018908', 'term': 'Muscle Weakness'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004872', 'term': 'Ergocalciferols'}], 'ancestors': [{'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Because of departure of study personnel and lack of funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2009-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-14', 'studyFirstSubmitDate': '2007-09-24', 'studyFirstSubmitQcDate': '2007-09-25', 'lastUpdatePostDateStruct': {'date': '2017-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vitamin D 2 levels of Dialysis Patients', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Muscle strength', 'timeFrame': '1 year', 'description': 'timed up and go test and dynamometry of four different muscle groups'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic Kidney disease', 'Dialysis', 'Vitamin D', 'Chronic kidney disease is associated with impaired muscle strength, pain and fractures.'], 'conditions': ['Kidney Disease', 'Muscle Weakness', 'Pain', 'Fractures, Bone']}, 'descriptionModule': {'briefSummary': 'Vitamin D is necessary for healthy bones. Vitamin D is made in our skin when we are exposed to sunlight, but it is also found in foods that we eat and in vitamin pills. Low levels of vitamin D are common in many groups of people, because we do not get enough sun during the winter and because we eat few foods that have vitamin D in them. Some foods with vitamin D are salmon, mackerel, tuna, and fortified milk, which has had vitamin D added to it.\n\nWe know that nearly all kidney disease patients on dialysis do not have enough vitamin D in their bodies. We believe this condition can cause muscle weakness, leading to falls and broken bones. These are common problems for patients who are receiving dialysis. For example, dialysis patients have a much higher risk of hip fractures (broken hips). However, no formal research has been done on patients with low vitamin D levels receiving dialysis, to see if they actually have muscle weakness and related problems.\n\nThere are two goals of this study. First, we want to see if patients on dialysis who have low vitamin D levels are actually at risk for muscle weakness, muscle pain, and broken bones. We also want to find out if giving vitamin D pills to these patients will result in better muscle strength, less muscle pain, and fewer falls.\n\nIn this study, we will compare vitamin D to placebo. Placebo capsules look exactly like vitamin D capsules but contain no active ingredients. We use placebos in research studies to be sure that the study results are due to the study drug and not to other reasons.', 'detailedDescription': 'Inclusion criteria:\n\nAge ³ 18, CKD on hemodialysis, men and women, hemoglobin ³ 9g/dl, albumin ³ 3.0g/dl, no recent (in the last three months) admissions to the hospital, ability to walk ten feet with or without a walking aid.\n\nExclusion criteria:\n\nSubjects who are pregnant or lactating; subjects with history of kidney stones, malabsorption syndromes, tertiary hyperparathyroidism defined by a parathyroid hormone of \\>500pg/ml, current use of corticosteroids, non-ambulatory subjects (for example paraplegic subjects), serious fracture in the last three months, and corrected calcium levels of 10.5 mg/dl or greater.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Chronic hemodialysis patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Age ³ 18\n* CKD on hemodialysis\n* Men and women\n* Hemoglobin ³ 9g/dl, albumin ³ 3.0g/dl,\n* No recent (in the last three months) admissions to the hospital\n* Ability to walk ten feet with or without a walking aid.\n\nExclusion criteria:\n\n* Subjects who are pregnant or lactating\n* Subjects with history of kidney stones\n* Malabsorption syndromes\n* Tertiary hyperparathyroidism defined by a parathyroid hormone of \\>500pg/ml, current use of corticosteroids\n* Non-ambulatory subjects (for example paraplegic subjects)\n* Serious fracture in the last three months, and\n* Corrected calcium levels of 10.5 mg/dl or greater.'}, 'identificationModule': {'nctId': 'NCT00535158', 'acronym': 'D2D', 'briefTitle': 'Vitamin D 2 to Dialysis Patients', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Vitamin D and Muscle Strength in the Dialysis Population', 'orgStudyIdInfo': {'id': '2007p-000613'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ergocalciferol (Vitamin D 2)', 'type': 'DRUG', 'description': '50,000units once weekly for 8 weeks then every other week for 4 weeks'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ajay K Singh, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brigham and Womens Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Ajay K. Singh', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}