Kidney FailureNCT00257439
Vitamin Metabolism in Kidney Disease
An observational study of Kidney Failure, run by Aalborg University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Failure
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2005to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. CKD, proteinuria 2. Healthy controls
Who may be able to join
- 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
Who cannot join
- Vitamin supplementation (exceeding predefined values)
- Renal replacement therapy (dialysis)
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Nephrology, Aalborg Hospital
Aalborg, DK-9000
Jakob Sølling, MD, PhD, +45 9932 1111 ext. 2237, aas.u19116@nja.dk
Henrik Birn, MD, PhD
About this study
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.
- Conditions
- Kidney Failure
- Keywords
- Vitamin B12, Folic Acid
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CKD | Elevated se-creatinine + proteinuria | |
| Healthy controls | Healthy controls, normal se-creatinine, no proteinuria |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2005 (estimated)
- Study startDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney FailureStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus, Aarhus University Hospital
- Responsible party
- Principal investigator, Henrik Birn, Aalborg University Hospital
- Investigators
- Henrik Birn, MD, PhD, Principal investigator, Department of Nephrology, Aalborg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00257439
- Sponsor's protocol ID
- VN 2005/44
- Status last verified
- Sep 2012
- First submitted
- 21 Nov 2005
- Last updated
- 25 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin Metabolism in Kidney Disease
- ClinicalTrials.gov ID
- NCT00257439
- Acronym / sponsor ID
- VN 2005/44
- Conditions
- Kidney Failure
- Keywords
- Vitamin B12, Folic Acid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus, Aarhus University Hospital
- Study start
- Dec 2005
- First posted
- 23 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CKD | – | –Elevated se-creatinine + proteinuria |
| Healthy controls | – | –Healthy controls, normal se-creatinine, no proteinuria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. CKD, proteinuria 2. Healthy controls
Key inclusion criteria (7 listed)
- Admission to the Department of Nephrology, Aalborg Hospital
- Elevated serum creatinine
- Proteinuria
- Informed and written consent
- Normal serum creatinine and creatinine clearance
Key exclusion criteria (2 listed)
- Vitamin supplementation (exceeding predefined values)
- Renal replacement therapy (dialysis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik Birn, MD, PhD principal investigator
Department of Nephrology, Aalborg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Failure, run by Aalborg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lars Mølby, MD (9932 1111 ext. 2241, moelby@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2012.