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Maintenance Vitamin D Therapy for Secondary Hyperparathyroidism (2HPT)

NCT00828347 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2016-01-25

Study results available
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Summary

There are still no established protocols for maintenance therapy with intravenous or oral vitamin D preparations after the iPTH target has been achieved.

Therefore, the present study compared the efficacy of two maintenance therapy protocols, i.e., oral administration of alfacalcidol (an oral vitamin D preparation) at a dose of 1.0 ug/day (higher-dose group) or at a dose of 0.25 ug/day (lower-dose group), in patients with secondary hyperparathyroidism who responded to initial maxacalcitol therapy, resulting in the control of iPTH to \< 150 pg/mL.

Conditions

  • Secondary Hyperparathyroidism

Interventions

DRUG

1.0 μg/day Alfacalcidol

We compared the efficacy of two protocols for maintenance therapy, which were oral administration of alfacalcidol at a dose of 1.0 μg/day in patients whose iPTH level was controlled to \< 150 pg/mL by initial maxacalcitol therapy.

DRUG

0.25 μg/day Alfacalcidol

We compared the efficacy of two protocols for maintenance therapy, which were oral administration of alfacalcidol at a dose of 0.25 μg/day in patients whose iPTH level was controlled to \< 150 pg/mL by initial maxacalcitol therapy.

Sponsors & Collaborators

  • Kumamoto University

    lead OTHER

Principal Investigators

  • Masataka Adachi, M.D., Ph.D. · Department nephrology Kumamoto University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • Japan

Study Locations

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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 NCT00828347 on ClinicalTrials.gov