NCT01222234

Brief Summary

This investigation will consist of a prospective study utilizing two separate populations of patients with 25(OH)D deficiency, one population with chronic kidney disease (CKD) and one with normal renal function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2010

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 18, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

May 16, 2016

Completed
Last Updated

May 16, 2016

Status Verified

April 1, 2016

Enrollment Period

1.8 years

First QC Date

October 13, 2010

Results QC Date

November 24, 2015

Last Update Submit

April 11, 2016

Conditions

Chronic Kidney Disease (CKD)End-stage Renal Disease (ESRD)

Outcome Measures

Primary Outcomes (2)

  • Monocyte Protein Expression

    Flow cytometry analysis of monocyte CD14, ACE, VDR, and Mac-1 expression

    8 weeks of therapy

  • Change in 24,25(OH)2D Levels in CKD vs. Non-CKD Subjects Receiving Cholecalciferol

    8 weeks of therapy

Study Arms (3)

Group 1: Cholecalciferol - CKD

EXPERIMENTAL

Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). They will be administered cholecalciferol 50,000 IU twice weekly for 8 weeks.

Drug: Cholecalciferol - CKD

Group 2: Calcitriol - CKD

EXPERIMENTAL

Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). They will be administered calcitriol 0.25mcg daily for 8 weeks.

Device: Calcitriol - CKD

Group 3: Cholecalciferol - non-CKD

EXPERIMENTAL

Patients in this arm have low vitamin D levels and normal kidney function. They will be administered cholecalciferol 50,000 IU twice weekly for 8 weeks.

Drug: Cholecalciferol - non-CKD

Interventions

Cholecalciferol - CKDDRUG

Cholecalciferol tablet 50,000 IU twice weekly for 8 weeks

Also known as: Vitamin D3
Group 1: Cholecalciferol - CKD
Calcitriol - CKDDEVICE

Calcitriol 0.25 mcg once daily for 8 weeks

Also known as: 1,25(OH)2D
Group 2: Calcitriol - CKD
Cholecalciferol - non-CKDDRUG

Cholecalciferol tablet 50,000 IU twice weekly for 8 weeks

Also known as: Vitamin D3
Group 3: Cholecalciferol - non-CKD

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic kidney disease w/GFR\<35ml/min
  • Nutritional vitamin D deficiency, defined as 25(OH)D \< 25ng/ml
  • Secondary hyperparathyroidism, PTH\>75pg/mL

You may not qualify if:

  • Active infection
  • Recent hospitalization for acute illness (within last month)
  • Refusal to study participation
  • History of chronic inflammatory disease process (i.e. inflammatory bowel, rheumatoid arthritis, SLE, etc.)
  • Allergy to cholecalciferol or calcitriol
  • History of parathyroidectomy
  • Functional renal transplant within 5 years
  • Current treatment with immunosuppressant medications
  • Noncompliance with prescribed medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicKidney Failure, Chronic

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Results Point of Contact

Title
Dr. Jason Stubbs
Organization
University of Kansas Medical Center
jstubbs@kumc.edu
913-588-9252

Study Officials

  • Jason Stubbs, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 13, 2010

First Posted

October 18, 2010

Study Start

October 1, 2010

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

May 16, 2016

Results First Posted

May 16, 2016

Record last verified: 2016-04

Locations

US(1)