Vitamin Metabolism in Kidney Disease

September 24, 2012 updated by: Henrik Birn, Aalborg University Hospital
The purpose of this study is to evaluate the urinary excretion and renal metabolism of vitamins, in particular vitamin B12 and folate, in relation to various renal conditions involving loss of renal function and/or proteinuria.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

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

  • Denmark
      • Aalborg, Denmark, DK-9000
        • Recruiting
        • Department of Nephrology, Aalborg Hospital
        • Contact:
        • Principal Investigator:
          • Henrik Birn, MD, PhD

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  1. CKD, proteinuria
  2. Healthy controls

Description

Inclusion Criteria:

  • Admission to the Department of Nephrology, Aalborg Hospital
  • Elevated serum creatinine
  • Proteinuria
  • Informed and written consent

Control subjects:

  • Normal serum creatinine and creatinine clearance
  • No proteinuria

Exclusion Criteria:

  • Vitamin supplementation (exceeding predefined values)
  • Renal replacement therapy (dialysis)

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
CKD
Elevated se-creatinine + proteinuria
Healthy controls
Healthy controls, normal se-creatinine, no proteinuria

Collaborators and Investigators

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

Sponsor

Aalborg University Hospital

Collaborators

Aarhus University Hospital
University of Aarhus

Investigators

  • Principal Investigator: Henrik Birn, MD, PhD, Department of Nephrology, Aalborg Hospital

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, 2005

Primary Completion

December 7, 2022

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

November 21, 2005

First Submitted That Met QC Criteria

November 21, 2005

First Posted (Estimate)

November 23, 2005

Study Record Updates

Last Update Posted (Estimate)

September 25, 2012

Last Update Submitted That Met QC Criteria

September 24, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VN 2005/44

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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