NCT00004468

Brief Summary

OBJECTIVES: I. Evaluate the long term safety and efficacy of orally administered calcitriol in patients with at least 5% of their body covered with psoriasis. II. Evaluate the long term safety and efficacy of topically administered calcitriol in patients with at least 5% of their body covered with psoriasis. III. Compare the topical calcitriol treatment to the oral calcitriol treatment in these patients.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1998

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 18, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 1999

Completed
Last Updated

March 2, 2018

Status Verified

February 1, 2018

First QC Date

October 18, 1999

Last Update Submit

February 28, 2018

Conditions

Psoriasis

Keywords

dermatologic disorderspsoriasisrare disease

Interventions

calcitriolDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Psoriasis covering at least 5% of body --Prior/Concurrent Therapy-- At least 30 days since prior systemic therapy for psoriasis At least 14 days since prior topical therapy for psoriasis No other concurrent treatment for psoriasis for the first 2-4 months of study No calcium supplement greater than 1,000 mg per day --Patient Characteristics-- No hypercalcemia No hypercalciuria Not pregnant Effective contraception required of all fertile patients

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Sponsors & Collaborators

MeSH Terms

Conditions

PsoriasisSkin DiseasesRare Diseases

Interventions

Calcitriol

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin and Connective Tissue DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DihydroxycholecalciferolsHydroxycholecalciferolsCholecalciferolCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Michael F. Holick

    Boston University

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 1999

First Posted

October 19, 1999

Study Start

October 1, 1998

Last Updated

March 2, 2018

Record last verified: 2018-02