Vitamin D Effect on Calcium Absorption on Persons on Hemodialysis

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01325610

Acronym

NEPH-Cal-D

Enrollment

Registered

2011-03-30

Start date

2011-04-30

Completion date

2012-02-29

Last updated

2012-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

vitamin D, kidney, renal

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.

Interventions

DIETARY_SUPPLEMENTcholecalciferol

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Vitamin D Status as measured by 25(OH)D levels	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.

Secondary

Measure	Time frame	Description
Calcium Absorption	12 weeks	A calcium absorption test will be done at baseline and after 12 weeks of vitamin D treatment.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026