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hCAP18 Levels and Vitamin D Deficiency in Chronic Kidney Disease

Primary Purpose

Chronic Kidney Disease, Vitamin D Deficiency

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ergocalciferol
Calcitriol
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Vitamin D, Chronic Kidney Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-80
  • Chronic Kidney Disease stage 3-4 (estimated glomerular filtration rate 15-60 ml/min)

Exclusion Criteria:

  • 6 month history of hypercalcemia, hyperphosphatemia, or nephrolithiasis
  • use of active vitamin D analog within 30 days
  • functioning renal transplant
  • Symptoms of active infection
  • Granulomatous disorders

Sites / Locations

  • Massachusetts Institute of Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ergocalciferol

calcitriol

Arm Description

Ergocalciferol intervention arm

calcitriol intervention arm

Outcomes

Primary Outcome Measures

hCAP18 levels

Secondary Outcome Measures

1,25-dihydroxyvitamin D
25-hydroxyvitamin D
calcium
phosphorus
Parathyroid hormone
T-cell subsets
Measures of different types of T-cells

Full Information

First Posted
December 2, 2009
Last Updated
September 21, 2015
Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Kidney Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01026363
Brief Title
hCAP18 Levels and Vitamin D Deficiency in Chronic Kidney Disease
Official Title
hCAP18 Levels and Vitamin D Deficiency in Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Inadequate enrollment
Study Start Date
December 2009 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Kidney Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The human immune system produces a protein called hCAP18 (also known as LL-37 or cathelicidin). This protein is believed to help the body to fight infections. Studies suggest that vitamin D may important in the production of hCAP18. This study is designed to test the ability of two different forms of vitamin D to affect levels of hCAP18. Vitamin D and hCAP18 levels will be measured during an initial visit. Individuals who are vitamin D deficient will be randomly assigned to receive one of two forms of vitamin D for two weeks. After this, follow-up levels will be measured.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Vitamin D Deficiency
Keywords
Vitamin D, Chronic Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ergocalciferol
Arm Type
Experimental
Arm Description
Ergocalciferol intervention arm
Arm Title
calcitriol
Arm Type
Experimental
Arm Description
calcitriol intervention arm
Intervention Type
Drug
Intervention Name(s)
Ergocalciferol
Other Intervention Name(s)
Vitamin D
Intervention Description
Ergocalciferol 50,000 IU capsule, one dose every other day x 5 doses
Intervention Type
Drug
Intervention Name(s)
Calcitriol
Other Intervention Name(s)
vitamin d
Intervention Description
0.25 mcg tablet once daily for 14 days
Primary Outcome Measure Information:
Title
hCAP18 levels
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
1,25-dihydroxyvitamin D
Time Frame
2 weeks
Title
25-hydroxyvitamin D
Time Frame
2 weeks
Title
calcium
Time Frame
2 weeks
Title
phosphorus
Time Frame
2 weeks
Title
Parathyroid hormone
Time Frame
2 weeks
Title
T-cell subsets
Description
Measures of different types of T-cells
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-80 Chronic Kidney Disease stage 3-4 (estimated glomerular filtration rate 15-60 ml/min) Exclusion Criteria: 6 month history of hypercalcemia, hyperphosphatemia, or nephrolithiasis use of active vitamin D analog within 30 days functioning renal transplant Symptoms of active infection Granulomatous disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ishir Bhan, MD MPH
Organizational Affiliation
Massachusetts General Hospital, Massachusetts Institute of Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts Institute of Technology
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02139
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19133797
Citation
Gombart AF, Bhan I, Borregaard N, Tamez H, Camargo CA Jr, Koeffler HP, Thadhani R. Low plasma level of cathelicidin antimicrobial peptide (hCAP18) predicts increased infectious disease mortality in patients undergoing hemodialysis. Clin Infect Dis. 2009 Feb 15;48(4):418-24. doi: 10.1086/596314.
Results Reference
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hCAP18 Levels and Vitamin D Deficiency in Chronic Kidney Disease

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