hCAP18 Levels and Vitamin D Deficiency in Chronic Kidney... | NCT01026363

Studies
hCAP18 Levels and Vitamin D Deficiency in Chronic Kidney Disease

NCT01026363

Sponsor

Massachusetts General Hospital

Status

Withdrawn

Last Update Posted

Sep 23, 2015Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Chronic Kidney Disease
Vitamin D Deficiency

Interventions

Ergocalciferol
Calcitriol

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1K23DK081677	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Inadequate enrollment

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

Jul 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Dec 2, 2009

First Submission Date that Met QC Criteria

Dec 2, 2009

First Posted Date

Dec 4, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2015

Last Update Posted Date

Sep 23, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ishir Bhan, MD, MPH, Assistant in Medicine, Massachusetts General HospitalPrincipal Investigator

Lead Sponsor

Massachusetts General HospitalOTHER

Collaborators

Name	Class
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH
National Kidney Foundation, United States	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ergocalciferol	Experimental	Ergocalciferol intervention arm	Drug: Ergocalciferol
calcitriol	Experimental	calcitriol intervention arm	Drug: Calcitriol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ergocalciferol	Drug	Ergocalciferol 50,000 IU capsule, one dose every other day x 5 doses	ergocalciferol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
hCAP18 levels		2 weeks

Secondary Outcomes

Measure	Description	Time Frame
1,25-dihydroxyvitamin D		2 weeks
25-hydroxyvitamin D		2 weeks
calcium

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ishir Bhan, MD MPH	Massachusetts General Hospital, Massachusetts Institute of Technology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts Institute of Technology		Cambridge	Massachusetts	02139	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19133797	Background	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.

ID	Term
D051436	Renal Insufficiency, Chronic
D014808	Vitamin D Deficiency

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

ID	Term
D004872	Ergocalciferols
D014807	Vitamin D
D002117	Calcitriol

ID	Term
D002782	Cholestenes
D002776	Cholestanes
D013256	Steroids
D000072473	Fused-Ring Compounds