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Clinical Trial Details

Trial ID: L1623
Source ID: NCT05549154
Associated Drug: High-Dose Vitamin D2 Softgels
Title: A Study on Prevention Strategies for CKD-SHPT and Related Complications Based on General Vitamin D Supplementation
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Chronic Kidney Disease 5D|Secondary Hyperparathyroidism Due to Renal Causes|Vitamin D Deficiency
Interventions: DRUG: High-dose vitamin D2 softgels|DRUG: low-dose vitamin D2 softgels|DRUG: placebo
Outcome Measures: Primary: Differences in changes in PTH levels from baseline to 6 months of intervention, baseline,at 6 months intervention | Secondary: Differences in changes in PTH levels from baseline to intervention at 1months、2months、3months、4months、5months, baseline,at 1,2,3,4,5 months intervention|Proportion of 25(OH)D >30ng/ml at 3 months of intervention, at 3 months intervention|Trends in changes in 25(OH)D levels from baseline to intervention at 1months、2months、3months、4months、5months、6months, baseline,at 1,2,3,4,5,6 months intervention|Incidence of cardiovascular events after 6 months of intervention, baseline,at 6 months intervention|Change in prevalence of vascular calcification at 6 months of intervention, We used cardiac ultrasound and lateral abdominal views to look for vascular calcification, baseline,at 6 months intervention|Change in Montreal Cognitive Assessment Scale scores at 6 months of intervention, A total score of 30 on this scale, with a score of ≥26 indicating normal; a score of \<26 indicates the presence of cognitive impairment: 18-26 for mild cognitive impairment, 10-17 for moderate cognitive impairment and \<10 for severe cognitive impairment, baseline,at 6 months intervention|Trends in blood calcium levels at 1 month, 2 months, 3 months, 4 months, 5 months and 6 months of intervention, baseline,at 1,2,3,4,5,6 months intervention|Trends in blood phosphorus levels at 1 month, 2 months, 3 months, 4 months, 5 months and 6 months of intervention, baseline,at 1,2,3,4,5,6 months intervention|Trends in FGF23 levels at 3 and 6 months of intervention, baseline,at 3,6 months intervention|Trends in Osteocalcin(OC) levels at 3 and 6 months of intervention, baseline,at 3,6 months intervention|Trends in Precollagen type I amino-terminal peptide(PINP) levels at 3 and 6 months of intervention, baseline,at 3,6 months intervention|Trends in β specific collagen degradation products(β-CTX) levels at 3 and 6 months of intervention, baseline,at 3,6 months intervention|Trends in ALP levels at 3 and 6 months of intervention, baseline,at 3,6 months intervention|Incidence of fractures at 6 months of intervention, Ask if the patient had a fracture during the intervention, the site of the fracture and the type of fracture, baseline,at 6 months intervention|Incidence of falls at 6 months of intervention, Ask if the patient has fallen during the intervention, the number of falls and the reasons for them, baseline,at 6 months intervention
Sponsor/Collaborators: Sponsor: First Affiliated Hospital Xi'an Jiaotong University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 372
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2022-12-05
Completion Date: 2023-10-30
Results First Posted:
Last Update Posted: 2023-01-09
Locations: The First Affiliated Hospital of Xi 'an Jiaotong University, Xi'an, Shaanxi, 710061, China
URL: https://clinicaltrials.gov/show/NCT05549154