Vitamin D Effect on Calcium Absorption on Persons on Hemodialysis (NEPH-Cal-D)
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|ClinicalTrials.gov Identifier: NCT01325610|
Recruitment Status : Completed
First Posted : March 30, 2011
Last Update Posted : April 4, 2012
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.
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease End Stage Renal Disease Vitamin D Deficiency||Dietary Supplement: cholecalciferol||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Oral Cholecalciferol (Vitamin D3) on Calcium Absorption in Persons on Long-term Hemodialysis|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||February 2012|
- Dietary Supplement: cholecalciferol
a weekly dose of 20,000 IU of vitamin D3 will be given orally for 12 weeks.Other Name: Maximum D3, cholecalciferol, 10,000IU/capsule, 0.25mg USP, Pro-Pharma LLA, Kirksville, Mo
- Vitamin D Status as measured by 25(OH)D levels [ Time Frame: 12 weeks ]A weekly dose of 20,000 IU of vitamin D3 will be taken by the particpant and blood drawn to measure levels at weeks 1, 3, 5, 8, 10, 13, and 18.
- Calcium Absorption [ Time Frame: 12 weeks ]A calcium absorption test will be done at baseline and after 12 weeks of vitamin D treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01325610
|United States, Nebraska|
|Omaha, Nebraska, United States, 68131|
|Principal Investigator:||Laura AG Armas, MD||Creighton University|