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Clinical Trial Details

Trial ID: L0594
Source ID: NCT01426724
Associated Drug: Contrast Enhanced Ultrasonography
Title: Effects of Vitamin D on Renal Blood Flow, Proteinuria and Inflammation in Patients With Chronic Kidney Disease
Acronym:
Status: WITHDRAWN
Study Results: NO
Results:
Conditions: Chronic Kidney Disease|Secondary Hyperparathyroidism
Interventions: DRUG: Contrast Enhanced Ultrasonography
Outcome Measures: Primary: Change in proteinuria compared to baseline as determined by spot urine protein to creatinine ratio (PCR), The pre to post-intervention change in urinary protein to creatinine ratio (PCR) will be analyzed either by way of the common paired Students t-test or the by way of paired Wilcoxon test. The paired Student t-test will be utilized if the measurements of the pre to post-intervention change in PCR are normally distribution, otherwise the ranked based paired Wilcoxon test will be utilized., Subjects must be on Vitamin D for 90 days (plus or minus 10 days) | Secondary: Change in renal blood flow compared to baseline as determined by contrast enhanced ultrasound., Baseline RBF will be measured using contrast enhanced ultrasound. subjects will be treated with one of the active forms of vitamin D for 90 days. Measurement of RBF usinf CEU will be repeated. Same statisticak methods will be used for this outcome as the primary outcome of the study., Subjects must be on Vitamin D for 90 days (plus or minus 10 days)|Association between changes from baseline in PCR and RBF, We will examine whether the pre-intervention to post-intervention changes in PCR were associated with changes in either renal blood flow. Spearman rank correlations and Spearman partial-rank correlations will be utilized to examine possible associations. With regard to hypothesis testing, the null hypothesis of no association will be rejected based on a p≤0.05 decision rule., Subjects must be on Vitamin D for 90 days (plus or minus 10 days)|Association between changes from baseline in PCR and GFR, We will examine whether the pre-intervention to post-intervention changes in PCR were associated with changes in GFR. Spearman rank correlations and Spearman partial-rank correlations will be utilized to examine possible associations. With regard to hypothesis testing, the null hypothesis of no association will be rejected based on a p≤0.05 decision rule., Subjects must be on Vitamin D for 90 days (plus or minus 10 days)|Association between changes from baseline in PCR and concentration of biomarkers of inflammation, We will examine whether the pre-intervention to post-intervention changes in PCR were associated with changes in CRP, IL-1, IL-6, or TNF-alpha. Spearman rank correlations and Spearman partial-rank correlations will be utilized to examine possible associations. With regard to hypothesis testing, the null hypothesis of no association will be rejected based on a p≤0.05 decision rule., Subjects must be on Vitamin D for 90 days (plus or minus 10 days)|Association between changes from baseline in PCR and activity of the renin angiotensin system., We will examine whether the pre-intervention to post-intervention changes in PCR were associated with changes in plasma renin-activity and plasma aldosterone concentration. Spearman rank correlations and Spearman partial-rank correlations will be utilized to examine possible associations. With regard to hypothesis testing, the null hypothesis of no association will be rejected based on a p≤0.05 decision rule., Subjects must be on Vitamin D for 90 days (plus or minus 10 days)
Sponsor/Collaborators: Sponsor: University of Virginia
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 0
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose:
Start Date: 2011-09
Completion Date: 2013-08
Results First Posted:
Last Update Posted: 2014-05-21
Locations: University of Virginia, Charlottesville, Virginia, 22908, United States
URL: https://clinicaltrials.gov/show/NCT01426724