Clinical trial NCT01325610: Vitamin D Effect on Calcium Absorption on Persons on Hemodialysis
Official title: The Effect of Oral Cholecalciferol (Vitamin D3) on Calcium Absorption in Persons on Long-term Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
End Stage Renal Disease
Vitamin D Deficiency
Keywords: vitamin D
kidney
renal
Lead sponsor: Creighton University
Sponsor class: OTHER
Collaborators: name: Dialysis Clinic, Inc.
First posted: 2011-03-30
Enrollment: 37
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Vitamin D Status as measured by 25(OH)D levels
timeFrame: 12 weeks
Secondary outcomes:
measure: Calcium Absorption
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
Study officials:
affiliation: Creighton University
name: Laura AG Armas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Graeff-Armas LA, Kaufmann M, Lyden E, Jones G. Serum 24,25-dihydroxyvitamin D3 response to native vitamin D2 and D3 Supplementation in patients with chronic kidney disease on hemodialysis. Clin Nutr. 2018 Jun;37(3):1041-1045. doi: 10.1016/j.clnu.2017.04.020. Epub 2017 Apr 30.
citation: Armas LA, Zena M, Lund R, Heaney RP. Calcium absorption response to cholecalciferol supplementation in hemodialysis. Clin J Am Soc Nephrol. 2013 Jun;8(6):1003-8. doi: 10.2215/CJN.08610812. Epub 2013 Feb 14.