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Vitamin D Effect on Calcium Absorption on Persons on Hemodialysis (NEPH-Cal-D)

Primary Purpose

Chronic Kidney Disease, End Stage Renal Disease, Vitamin D Deficiency

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

cholecalciferol

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring vitamin D, kidney, renal

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Creighton University

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Calcium Absorption

A calcium absorption test will be done at baseline and after 12 weeks of vitamin D treatment.

Full Information

NCT ID

NCT01325610

First Posted

January 17, 2011

Last Updated

April 3, 2012

Sponsor

Creighton University

Collaborators

Dialysis Clinic, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01325610

Brief Title

Vitamin D Effect on Calcium Absorption on Persons on Hemodialysis

Acronym

NEPH-Cal-D

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Completed

Study Start Date

April 2011 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Creighton University

Collaborators

Dialysis Clinic, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Kidney Disease, End Stage Renal Disease, Vitamin D Deficiency

Keywords

vitamin D, kidney, renal

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Dietary Supplement

Intervention Name(s)

cholecalciferol

Other Intervention Name(s)

Maximum D3, cholecalciferol, 10,000IU/capsule, 0.25mg USP, Pro-Pharma LLA, Kirksville, Mo

Intervention Description

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

Primary Outcome Measure Information:

Title

Vitamin D Status as measured by 25(OH)D levels

Description

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.

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Calcium Absorption

Description

A calcium absorption test will be done at baseline and after 12 weeks of vitamin D treatment.

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laura AG Armas, MD

Organizational Affiliation

Creighton University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Creighton University

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68131

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

28506446

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.

Results Reference

derived

PubMed Identifier

23411428

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.

Results Reference

derived

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Vitamin D Effect on Calcium Absorption on Persons on Hemodialysis

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