|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
13 May 2013 |
|
Main ID: |
NCT01026363 |
|
Date of registration:
|
02/12/2009 |
|
Primary sponsor: |
|
|
Public title:
|
hCAP18 Levels and Vitamin D Deficiency in Chronic Kidney Disease
|
|
Scientific title:
|
hCAP18 Levels and Vitamin D Deficiency in Chronic Kidney Disease |
|
Date of first enrolment:
|
December 2009 |
|
Target sample size:
|
60 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT01026363 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Dorothy Sullivan, RN |
|
Address:
|
|
|
Telephone:
|
617-726-5382 |
|
Email:
|
DSULLIVAN18@PARTNERS.ORG |
|
Affiliation:
|
|
|
|
Name:
|
Dorothy Sullivan, RN |
|
Address:
|
|
|
Telephone:
|
617-726-5382 |
|
Email:
|
DSULLIVAN18@PARTNERS.ORG |
|
Affiliation:
|
|
|
|
Name:
|
Ishir Bhan, MD MPH |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Massachusetts General Hospital, Massachusetts Institute of Technology |
|
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Chronic Kidney Disease
|
|
Vitamin D Deficiency
|
|
Intervention(s)
|
|
Drug: Calcitriol
|
|
Drug: Ergocalciferol
|
|
Primary Outcome(s)
|
|
hCAP18 levels
[Time Frame: 2 weeks]
|
|
Secondary Outcome(s)
|
|
1,25-dihydroxyvitamin D
[Time Frame: 2 weeks]
|
|
25-hydroxyvitamin D
[Time Frame: 2 weeks]
|
|
calcium
[Time Frame: 2 weeks]
|
|
Parathyroid hormone
[Time Frame: 2 weeks]
|
|
phosphorus
[Time Frame: 2 weeks]
|
|
T-cell subsets
[Time Frame: 2 weeks]
|
|
Secondary ID(s)
|
|
1K23DK081677
|
|
2009-P-001050/1
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|