hCAP18 Levels and Vitamin D Deficiency in Chronic Kidney Disease

September 21, 2015 updated by: Ishir Bhan, MD, MPH, Massachusetts General Hospital
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02139
        • Massachusetts Institute of Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ergocalciferol
Ergocalciferol intervention arm
Drug: Ergocalciferol
Ergocalciferol 50,000 IU capsule, one dose every other day x 5 doses
Other Names:
  • Vitamin D
Experimental: calcitriol
calcitriol intervention arm
Drug: Calcitriol
0.25 mcg tablet once daily for 14 days
Other Names:
  • vitamin d

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
hCAP18 levels
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1,25-dihydroxyvitamin D
Time Frame: 2 weeks
2 weeks
25-hydroxyvitamin D
Time Frame: 2 weeks
2 weeks
calcium
Time Frame: 2 weeks
2 weeks
phosphorus
Time Frame: 2 weeks
2 weeks
Parathyroid hormone
Time Frame: 2 weeks
2 weeks
T-cell subsets
Time Frame: 2 weeks
Measures of different types of T-cells
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Kidney Foundation

Investigators

  • Principal Investigator: Ishir Bhan, MD MPH, Massachusetts General Hospital, Massachusetts Institute of Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

December 2, 2009

First Submitted That Met QC Criteria

December 2, 2009

First Posted (Estimate)

December 4, 2009

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 21, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-P-001050/1
  • 1K23DK081677 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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