NCT00257439

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 23, 2005

Completed
8 days until next milestone

Study Start

First participant enrolled

December 1, 2005

Completed
Last Updated

September 25, 2012

Status Verified

September 1, 2012

First QC Date

November 21, 2005

Last Update Submit

September 24, 2012

Conditions

Kidney Failure

Keywords

Vitamin B12Folic Acid

Study Arms (2)

CKD

Elevated se-creatinine + proteinuria

Healthy controls

Healthy controls, normal se-creatinine, no proteinuria

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1. CKD, proteinuria 2. Healthy controls

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nephrology, Aalborg Hospital

Aalborg, DK-9000, Denmark

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Henrik Birn, MD, PhD

    Department of Nephrology, Aalborg Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lars Mølby, MD

CONTACT

9932 1111moelby@dadlnet.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 21, 2005

First Posted

November 23, 2005

Study Start

December 1, 2005

Last Updated

September 25, 2012

Record last verified: 2012-09

Locations

DK(1)