Vitamin D Effect on Calcium Absorption on Persons on Hemodialysis

Chronic Kidney Disease Clinical Trial

— NEPH-Cal-D  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01325610
• Other study ID #: #10-15975
• Status: Completed
• Phase: N/A
• First received: January 17, 2011
• Last updated: April 3, 2012
• Start date: April 2011
• Est. completion date: February 2012

Study information

• Verified date: April 2012
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: February 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• on hemodialysis

• > 19 years of age

Exclusion Criteria:

• Pregnancy or planned pregnancy

• Hypercalcemia (> 10.2 mg/dl) at baseline

• Chronic GI disease

• Liver dysfunction

• Taking steroids

• Received any investigational drugs within 4 weeks

• Any allergy to vitamin D3

• Chronic vitamin D intake > 1,000 IU daily

• Dialysate concentration (calcium 2.5mg/L) which is to remain constant during Rx

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• cholecalciferol
a weekly dose of 20,000 IU of vitamin D3 will be given orally for 12 weeks.

Locations

Country	Name	City	State
United States	Creighton University	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Creighton University	Dialysis Clinic, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitamin D Status as measured by 25(OH)D levels	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.	12 weeks	No
Secondary	Calcium Absorption	A calcium absorption test will be done at baseline and after 12 weeks of vitamin D treatment.	12 weeks	No