Study Stopped
Inadequate enrollment
hCAP18 Levels and Vitamin D Deficiency in Chronic Kidney Disease
2 other identifiers
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2009
Longer than P75 for not_applicable
1 active site
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
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 2, 2009
CompletedFirst Posted
Study publicly available on registry
December 4, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedSeptember 23, 2015
September 1, 2015
4.6 years
December 2, 2009
September 21, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
hCAP18 levels
2 weeks
Secondary Outcomes (6)
1,25-dihydroxyvitamin D
2 weeks
25-hydroxyvitamin D
2 weeks
calcium
2 weeks
phosphorus
2 weeks
Parathyroid hormone
2 weeks
- +1 more secondary outcomes
Study Arms (2)
ergocalciferol
EXPERIMENTALErgocalciferol intervention arm
calcitriol
EXPERIMENTALcalcitriol intervention arm
Interventions
Ergocalciferol 50,000 IU capsule, one dose every other day x 5 doses
Eligibility Criteria
You may qualify if:
- Age 18-80
- Chronic Kidney Disease stage 3-4 (estimated glomerular filtration rate 15-60 ml/min)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts Institute of Technology
Cambridge, Massachusetts, 02139, United States
Related Publications (1)
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.
PMID: 19133797BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ishir Bhan, MD MPH
Massachusetts General Hospital, Massachusetts Institute of Technology
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 in Medicine
Study Record Dates
First Submitted
December 2, 2009
First Posted
December 4, 2009
Study Start
December 1, 2009
Primary Completion
July 1, 2014
Study Completion
December 1, 2014
Last Updated
September 23, 2015
Record last verified: 2015-09