Pharmacokinetic Comparison of Vitamin's D2 and D3 in Stage 5 Chronic Kidney Disease Patients on Chronic Hemodialysis

Pharmacokinetic Comparison of Vitamin's D2 and D3 in Stage 5 Chronic Kidney

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01675557

Enrollment

Registered

2012-08-30

Start date

2012-09-30

Completion date

2013-05-31

Last updated

2015-02-26

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

Conditions

Chronic Kidney Disease

Keywords

chronic kidney disease

Brief summary

The purpose of this study is to compare the pharmacokinetic 25(OH)D and 1,25(OH)2D responses to a single oral dose of vitamin D2 or vitamin D3 in a group of Stage 5-Chronic Kidney Disease subjects requiring chronic hemodialysis.

Detailed description

This is a randomized, single blind, controlled study. Subjects will be randomly assigned to receive 1) placebo capsules (control group); 2) capsules with ergocalciferol (the vitamin D2 group); or 3) capsules with cholecalciferol (the vitamin D3 group).

Interventions

DIETARY_SUPPLEMENTVitamin D3

a single oral dose of vitamin D3

DIETARY_SUPPLEMENTVitamin D2

a single oral dose of vitamin D2

DIETARY_SUPPLEMENTPlacebo

a single oral dose of placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

Healthy volunteers

Inclusion criteria

* 30 men and women, ages 20-65, BMI 18-30, requiring chronic hemodialysis

Exclusion criteria

* They will habitually consume less than 16 oz of milk per day and get less than 10 hours of sun exposure per week. We will exclude those with granulomatous conditions, cirrhotic liver disease, and those taking anticonvulsants, barbiturates, or steroids in any form or any investigational drugs within 4 weeks. We will exclude those with pregnancy or planned pregnancy, hypercalcemia (\>10.4 mg/dl) previously recorded, chronic GI disease which would interfere with absorption, any allergy to vitamin D3, or chronic vitamin D intake \>1,000 IU daily. Subjects will continue to take a calcitriol analogue and phosphorus binder as prescribed by their nephrologist. Calcitriol analogues are to be documented and remain constant throughout study.

Design outcomes

Primary

Measure	Time frame	Description
25(OH)D	16 weeks	25(OH)D levels will be drawn at intervals over 16 weeks.

Countries

United States

Outcome results

None listed

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