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Vitamin D Effect on Calcium Absorption on Persons on Hemodialysis

NCT01325610 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2012-04-04

No results posted yet for this study

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

DIETARY_SUPPLEMENT

cholecalciferol

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

Sponsors & Collaborators

  • Dialysis Clinic, Inc.

    collaborator INDUSTRY

  • Creighton University

    lead OTHER

Principal Investigators

  • Laura AG Armas, MD · Creighton University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-01-31
Completion
2012-02-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01325610 on ClinicalTrials.gov