RENAL INSUFFICIENCY, CHRONICNCT00397475
Evaluation of Colecalciferol Substitution in Dialysis Patients
A study testing Colecalciferol in people with RENAL INSUFFICIENCY, CHRONIC and Hyperparathyroidism, Secondary, run by University Hospital, Saarland at 1 site in Germany.
Trial summary
The purpose of this study is to determine the effect of a colecalciferol substitution in dialysis patients on bone metabolism and immune system Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- RENAL INSUFFICIENCY, CHRONIC, Hyperparathyroidism, Secondary
- What is being tested?
- Colecalciferol
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2006to Mar 2007
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Serum 25-OH-Vit.D-levels < 60 ng/ml
- Age > 18 years
- dialysis treatment > 3 Months
- signed written informed consent
- Serum-Calcium-levels < 2,6 mmol/l within the last 4 weeks
- Serum-Phosphate-levels < 7,0 mg/dl within the last 4 weeks
- Ca x P-Product < 75 mg2/dl2 within the last 4 weeks
Who cannot join
- Serum 25-OH-Vit.-D-levels > 60 ng/ml
- concommitant participation in another interventional trial
- psychiatric disorders preventing from valid informed consent
- Hyperphosphatemia (> 7,0 mg/dl) within the last 4 weeks
- Hypercalcemia (> 2,6 mmol/l) within the last 4 weeks
- Ca x P-Product > 75 mg2/dl2 within the last 4 weeks
Show all 20Show fewer
- pregnancy or lactation
- known malignancy
- liver disease, defined as 2-fold upper limit of ASAT-, or ALAT-levels
- PTH levels < 50 pg/ml
- current clinically relevant infections treated with antibiotic therapy and raised hsCRP levels
- Chronic viral Infectious diseases (e.g. HIV, Hepatitis B or C)
- Immunosuppressant Medication
- known hematologic disorders, other than renal anemia
- age below 18 years
- known anaphylactic reaction against the study medication or other ingredients of the study drug preparation
- renal calculus
- Pseudohypoparathyroidism
- Medication including cardiac glycosides
- Sarkoidosis
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital of Saarland, Dpt. of Internal Medicine IV, Div. of Nephrology and Hypertension
Homburg, Saarland, 66421
About this study
The purpose of this study is to determine the effect of a colecalciferol substitution in dialysis patients on bone metabolism and immune system
- Being tested
- Colecalciferol
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperparathyroidism, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColecalciferolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
CD14/CD16-Monocyte-Subsets (Frequency)
Secondary outcomes (3)
Production of Cytokines: IFN-γ, TNF-α
Serum levels of Calcium, Phosphorus, iPTH, hsCRP, alkaline phosphatase
Th1/Th2- and Tc1/Tc2-Lymphocyte-Frequency
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2006 (estimated)
- Study startNov 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RENAL INSUFFICIENCY, CHRONICStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Saarland
- Sponsor type
- University, hospital or other
- Investigators
- Eric Seibert, M.D., Principal investigator, University Hospital of Saarland, Dpt. of Internal Medicine IV, Div. of Nephrology and Hypertension
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00397475
- Sponsor's protocol ID
- 142/06
- Status last verified
- May 2015
- First submitted
- 7 Nov 2006
- Last updated
- 27 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Colecalciferol Substitution in Dialysis Patients
- ClinicalTrials.gov ID
- NCT00397475
- Acronym / sponsor ID
- 142/06
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, SaarlandUniversity, hospital or other
- Study start
- Nov 2006
- Study completion
- Mar 2007 (actual)
- First posted
- 9 Nov 2006 (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 determine the effect of a colecalciferol substitution in dialysis patients on bone metabolism and immune system
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Serum 25-OH-Vit.D-levels < 60 ng/ml
- Age > 18 years
- dialysis treatment > 3 Months
- signed written informed consent
- Serum-Calcium-levels < 2,6 mmol/l within the last 4 weeks
Key exclusion criteria (20 listed)
- Serum 25-OH-Vit.-D-levels > 60 ng/ml
- concommitant participation in another interventional trial
- psychiatric disorders preventing from valid informed consent
- Hyperphosphatemia (> 7,0 mg/dl) within the last 4 weeks
- Hypercalcemia (> 2,6 mmol/l) within the last 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colecalciferol | Drug | – |
Primary outcome
CD14/CD16-Monocyte-Subsets (Frequency)
3 secondary outcomes
Production of Cytokines: IFN-γ, TNF-α
Serum levels of Calcium, Phosphorus, iPTH, hsCRP, alkaline phosphatase
Th1/Th2- and Tc1/Tc2-Lymphocyte-Frequency
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
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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.
Eric Seibert, M.D. principal investigator
University Hospital of Saarland, Dpt. of Internal Medicine IV, Div. of Nephrology and Hypertension
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colecalciferol in people with RENAL INSUFFICIENCY, CHRONIC and Hyperparathyroidism, Secondary, run by University Hospital, Saarland at 1 site in Germany.
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 20 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: finished, as of the sponsor's last update on 27 May 2015. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CD14/CD16-Monocyte-Subsets (Frequency). It is what the study was designed to measure, not a finding.
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 27 May 2015.