Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT05399251
Status:
COMPLETED
Last Update Posted:
2022-06-01
First Post:
2022-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Relationship Between Serum 1,25-dihydroxy Vitamin D and Markers of Bone Metabolism in Renal Dysfunction Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012080', 'term': 'Chronic Kidney Disease-Mineral and Bone Disorder'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D012279', 'term': 'Rickets'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'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': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D006962', 'term': 'Hyperparathyroidism, Secondary'}, {'id': 'D006961', 'term': 'Hyperparathyroidism'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1553}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-29', 'studyFirstSubmitDate': '2022-02-14', 'studyFirstSubmitQcDate': '2022-05-29', 'lastUpdatePostDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'concentration of serum 1,25 dihydroxy vitamin D in U/L in five stages of chronic kidney disease', 'timeFrame': '7 year', 'description': 'In CKD, 1-alfa-hydroxylase activity in the kidneys is reduced, leading to decreases in the level of the activated form of vitamin D (1,25- dihydroxy vitamin D), resulting in secondary hyperparathyroidism and bone disease. This study aimed to determine the concentration of 1,25 dihydroxy vitamin D in different stages of CKD.'}, {'measure': 'concentration of serum calcium in mg/dl in five stages of chronic kidney disease', 'timeFrame': '7 years', 'description': 'in renal tubules, 1,25- dihydroxy vitamin D increase reabsorption of calcium from renal filtrate and thus stabilize blood calcium levels. in CKD, with deterioration of kidney function, stage V, the levels of calcium drops resulting in hypocalcemia.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['renal dysfunction', 'bone metabolism marker', '1,25(OH)2 vitamin D'], 'conditions': ['Chronic Kidney Disease-Mineral and Bone Disorder']}, 'descriptionModule': {'briefSummary': 'This cross-sectional study was conducted, including those subjects tested for 1,25(OH)2D during Jan 2015-Dec 2021. Estimated glomerular filtration rate (eGFR) was calculated and subjects were classified into chronic kidney disease (CKD) stages. Associations between biochemical marker, calcium, phosphorus, magnesium, alkaline phosphatase, 1,25(OH)2D and CKD stages was determined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Laboratory data of patients tested for 1,25(OH)2D from January 2015 to December 2021 was retrieved from laboratory integrated systems (ILMS), and only the initial results for 1,25(OH)2D were included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Data of serum 1,25(OH)2D available\n\nExclusion Criteria:\n\n• Serum1,25(OH)2D is not available'}, 'identificationModule': {'nctId': 'NCT05399251', 'briefTitle': 'Relationship Between Serum 1,25-dihydroxy Vitamin D and Markers of Bone Metabolism in Renal Dysfunction Patients', 'organization': {'class': 'OTHER', 'fullName': 'Aga Khan University Hospital, Pakistan'}, 'officialTitle': 'Relationship Between Serum 1,25-dihydroxy Vitamin D and Markers of Bone Metabolism in Renal Dysfunction Patients', 'orgStudyIdInfo': {'id': 'ERC # 2020-3295-14097'}}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aga Khan University Hospital, Pakistan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PRINCIPAL INVESTIGATOR', 'investigatorFullName': 'Zaib Un Nisa Khan', 'investigatorAffiliation': 'Aga Khan University Hospital, Pakistan'}}}}