NCT01364688

Brief Summary

Active vitamin D at therapeutic dose may prevent vascular calcification but in supraphysiologic dose may precipitate it.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2011

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 2, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

June 2, 2011

Status Verified

May 1, 2011

Enrollment Period

1.5 years

First QC Date

May 26, 2011

Last Update Submit

May 31, 2011

Conditions

Vascular Calcification

Keywords

coronary calcificationvascular calcificationactive vitamin Dalfacalcidol

Outcome Measures

Primary Outcomes (1)

  • Change in Coronary Artery Calcification

    6 months and 12 months

Study Arms (2)

Treatment

EXPERIMENTAL

oral alfacalcidol

Drug: oral alfacalcidol

Control

NO INTERVENTION

No drug

Drug: no drug

Interventions

oral alfacalcidolDRUG

Oral alfacalcidol 0.5 microgram per day

Treatment
no drugDRUG

no drug

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Predialysis chronic kidney disease with GFR \< 90 mL/min/1.73m2
  • PTH above the upper limit of normal
  • serum calcium and phosphate below the upper limit of normal

You may not qualify if:

  • changes in GFR\>15% during the past 3 months
  • receive elemental calcium\>500 mg/day
  • currently taking active vitamin D, oral calcium with elemental calcium\>500 mg/day or bisphosphonate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Ramathibodi Hospital, Mahidol University

Phayathai, Bangkok, 10400, Thailand

RECRUITING

MeSH Terms

Conditions

Vascular Calcification

Interventions

alfacalcidol

Condition Hierarchy (Ancestors)

CalcinosisCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Sinee Disthabanchong, MD

CONTACT

+6622011116tesdb@mahidol.ac.th

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 26, 2011

First Posted

June 2, 2011

Study Start

May 1, 2011

Primary Completion

November 1, 2012

Study Completion

December 1, 2012

Last Updated

June 2, 2011

Record last verified: 2011-05

Locations

TH(1)