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Trials / Completed

CompletedNCT01325610

Vitamin D Effect on Calcium Absorption on Persons on Hemodialysis

The Effect of Oral Cholecalciferol (Vitamin D3) on Calcium Absorption in Persons on Long-term Hemodialysis

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
37 (actual)
Sponsor
Creighton University · Academic / Other
Sex
All
Age
19 Years
Healthy volunteers
Not accepted

Summary

The assumption has been that 1,25(OH)2D is solely responsible for calcium absorption. That has been one of the presumed causes of hyperparathyroidism in chronic kidney disease (CKD) (low 1,25(OH)2D leads to decreased calcium absorption, which increases parathyroid hormone release in compensation). Replacing 1,25 D directly has been the goal with using 1,25D or its analogues in CKD. There is very little data concerning use of native vitamin D or 25(OH)D in CKD, although autocrine functions in extrarenal tissues would use 25(OH)D. The latest KDIGO guidelines do recognize the autocrine role of vitamin D, but have no data on outcomes or doses or optimal levels to guide them and so have made a blanket recommendation to treat 25D levels in CKD by general healthy population guidelines. 1. This project focuses on an outcome (calcium absorption) that may be impacted by optimizing 25D status in renal patients. The investigators will assume for this project that a level of 25D \> 32 ng/ml is optimal in CKD patients as in a healthy population. 2. A secondary outcome is to quantify calcium absorption in CKD patients with and without vitamin D repletion and to quantify systemic 1,25D levels. This may clarify the roles 25D and 1,25D play in calcium absorption.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTcholecalciferola weekly dose of 20,000 IU of vitamin D3 will be given orally for 12 weeks.

Timeline

Start date
2011-04-01
Primary completion
2012-01-01
Completion
2012-02-01
First posted
2011-03-30
Last updated
2012-04-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01325610. Inclusion in this directory is not an endorsement.

Vitamin D Effect on Calcium Absorption on Persons on Hemodialysis (NCT01325610) · Clinical Trials Directory