Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2026-01-01 @ 8:17 PM
Study NCT ID:
NCT03073369
Status:
WITHDRAWN
Last Update Posted:
2018-03-15
First Post:
2017-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Ergocalciferol on Iron Metabolism in Individuals With Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}, {'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': "Study didn't materialize for various reasons.", 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-14', 'studyFirstSubmitDate': '2017-02-28', 'studyFirstSubmitQcDate': '2017-03-02', 'lastUpdatePostDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in serum hepcidin levels', 'timeFrame': 'At Day 0, Day 3, 1 week, 4 weeks and 6 weeks', 'description': 'Difference in change in serum hepcidin levels (ng/ml) over time between the two groups'}], 'secondaryOutcomes': [{'measure': 'Change in serum hemoglobin level', 'timeFrame': 'At Day 0, Day 3, 1 week, 4 weeks and 6 weeks', 'description': 'Difference in change in serum hemoglobin levels (g/dL) over time between the two groups'}, {'measure': 'Change in serum ferritin level', 'timeFrame': 'At Day 0, Day 3, 1 week, 4 weeks and 6 weeks', 'description': 'Difference in change in serum ferritin levels (ng/ml) over time between the two groups'}, {'measure': 'Change in percent transferrin saturation', 'timeFrame': 'At Day 0, Day 3, 1 week, 4 weeks and 6 weeks', 'description': 'Difference in change in percent transferrin saturation (%) over time between the two groups'}, {'measure': 'Change in serum iron level', 'timeFrame': 'At Day 0, Day 3, 1 week, 4 weeks and 6 weeks', 'description': 'Difference in change in serum iron levels (mcg/dL) over time between the two groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['CKD', 'Chronic Kidney Diseases', 'Hepcidin', 'Ergocalciferol', 'Vitamin D', 'Iron-deficiency', 'Anemia']}, 'descriptionModule': {'briefSummary': "The purpose of the study is to learn more about how treatment with vitamin D can affect iron metabolism and blood levels of hepcidin (hormone controlling iron levels) in people with chronic kidney disease (CKD).\n\nIron is an essential mineral which is a major component of proteins that carry oxygen in the blood. Problems with iron metabolism can lead to low blood levels (anemia), which can commonly happen in people with CKD.\n\nNew research over the last decade has uncovered a new hormone called 'hepcidin', which is made in the liver and released into the blood. Hepcidin controls how much iron is in the blood by preventing the absorption of iron from food. Blood levels of hepcidin C are found to be high in people with CKD, and a recent small study in people with normal kidney function showed that treatment with vitamin D decreased hepcidin levels.\n\nIn this study, investigators would like to examine the effects of vitamin D (Ergocalciferol) on iron metabolism and blood levels of hepcidin in individuals with CKD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants 19 years or older with mild to moderate CKD (eGFR 15 - 59 ml/min/1.73 m2) by the CKD-EPI formula, with vitamin D deficiency (25(OH)D \\< 30 ng/ml), and with absolute iron deficiency (TSAT \\< 20 and Ferritin \\<100) or iron restriction (TSAT \\< 20 and Ferritin \\> 100).\n\nExclusion Criteria:\n\n* Active vitamin D analog therapy or history of recent (\\< 3 months) use.\n* Nutritional vitamin D (cholecalciferol or ergocalciferol) therapy in dosages greater than 2000 IU/day.\n* Subjects receiving erythropoiesis stimulating agents or intravenous iron therapy.\n* Oral iron therapy started within the last 3 months.\n* Hb \\< 8.0 g/dL for males and Hb \\<7.0 g/dL for females.\n* Pregnancy or lactation.\n* Serum calcium \\> 10.0 mg/dL or phosphorus \\> 4.5 mg/dL.\n* Subjects with acute kidney injury or rapidly declining GFR.\n* Subjects on hemodialysis, peritoneal dialysis, or having a functioning renal transplant.\n* Focus of active inflammation such as acute gout, rheumatoid arthritis or active infection determined clinically.'}, 'identificationModule': {'nctId': 'NCT03073369', 'briefTitle': 'Effect of Ergocalciferol on Iron Metabolism in Individuals With Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Targeting the Interactions Between Disordered Iron Homeostasis and Mineral Metabolism in Chronic Kidney Disease (Aim 1)', 'orgStudyIdInfo': {'id': 'F170216006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Oral Ergocalciferol', 'description': 'Oral Ergocalciferol 50000 IU once daily for 6 weeks', 'interventionNames': ['Drug: Ergocalciferol 50000 UNT']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ergocalciferol 50000 UNT', 'type': 'DRUG', 'description': 'Oral Ergocalciferol 50000 IU once daily for 6 weeks', 'armGroupLabels': ['Oral Ergocalciferol']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral Placebo - one capsule once daily for 6 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Heart Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Bhupesh Panwar, MD', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}