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Vitamin D Deficiency in Chronic Kidney Disease (CKD) Patients

NCT00958451 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2011-03-24

No results posted yet for this study

Summary

This is an open label, single center, randomized, active comparator controlled study, comparing the effects of vitamin D replacement using oral ergocalciferol versus paricalcitol on parathyroid hormone (PTH) levels in patients with stage 3 and 4 CKD and vitamin D deficiency or insufficiency. The purpose of this study is to determine which of these two approaches is more successful.

Conditions

Interventions

DRUG

Paricalcitol

1. Patients will receive 1mcg once daily orally if iPTH is less than 500pg/ml; 2. Patients will receive 2mcg once daily orally if iPTH is more than 500pg/ml. Duration of administration will be 16 weeks.

DRUG

Ergocalciferol

1. If baseline 25 OHD level is less than 5ng/mml: ergocalciferol 50,000 units once a week orally for 12 weeks, then 50,000 units monthly for total duration of 16 weeks. 2. If baseline 25 OHD is between 5 and 15mg/ml: Ergocalciferol 50,000 units once a week orally for 4 weeks, then 50,000 units once a month for total duration of 16 weeks. 3. If baseline 25 OHD level is between 16 and 30ng/ml: Ergocalciferol 50,000 units orally once every 4 weeks for 16 weeks.

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Salem Veterans Affairs Medical Center

    lead FED

Principal Investigators

  • Csaba P. Kovesdy, M.D. · Salem VAMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT00958451 on ClinicalTrials.gov