Hydroxylase DeficiencyNCT04237480
Influence of Kidney Performance and Magnesium on Formation of (OH)2-vitamin D3
An observational study of Hydroxylase Deficiency, run by University Hospital, Basel, Switzerland.
Trial summary
Retrospective database analysis. The target values are the serum values of 25(OH)D, of 1,25(OH)2D, of magnesium and creatinine as well as age and sex of the patients. The laboratory values of the years 2017 and 2018 are included. There are no additional measurements on patients. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hydroxylase Deficiency
- What is being tested?
- serum value 1,25(OH)2 vitamin D
- How many people
- 50,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 28 May 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: no restriction
Who may be able to join
- all data sets available
Who cannot join
- a declaration from the patient that his laboratory values may not be included in an evaluation.
About this study
Official title: Influence of Kidney Performance and Magnesium on the Biomarkers of Vitamin D
Retrospective database analysis. The target values are the serum values of 25(OH)D, of 1,25(OH)2D, of magnesium and creatinine as well as age and sex of the patients. The laboratory values of the years 2017 and 2018 are included. There are no additional measurements on patients.
Read the detailed description
The laboratory values of the years 2017 and 2018 are included. All laboratory results to be evaluated originate from Medics Labor in Bern. We expect about 50'000 data sets. It is impossible for the study team to draw conclusions about the patients or the senders.
- Conditions
- Hydroxylase Deficiency
- Being tested
- serum value 1,25(OH)2 vitamin D
- Keywords
- vitamin D, 1-alpha hydroxylase, magnesium, renal insufficiency
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum value 1,25(OH)2 vitamin DDiagnostic test
Also called serum value 25(OH) vitamin D, serum value magnesium, serum value creatinine
statistical evaluation of the serum values
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation of serum values of 1,25(OH)2 vitamin D with estimated glomerular filtration rate
statistical evaluation of serum values
Measured: 2017 - 2018
correlation of serum values of 1,25(OH)2 vitamin D with magnesium
statistical evaluation of serum values
Measured: 2017 - 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start1 Jan 2017
- Primary completion31 Dec 2018
- Study completion28 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hydroxylase DeficiencyStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Retrospective
- Enrolment
- 50,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237480
- Sponsor's protocol ID
- 2018-00923
- Other IDs
- 2018
- Status last verified
- Feb 2020
- First submitted
- 17 Jan 2020
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Kidney Performance and Magnesium on the Biomarkers of Vitamin D
- ClinicalTrials.gov ID
- NCT04237480
- Acronym / sponsor ID
- 2018-00923
- Conditions
- Hydroxylase Deficiency
- Keywords
- vitamin D, 1-alpha hydroxylase, magnesium, renal insufficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50,000 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 28 May 2019 (actual)
- First posted
- 23 Jan 2020 (actual)
- 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.
Retrospective database analysis. The target values are the serum values of 25(OH)D, of 1,25(OH)2D, of magnesium and creatinine as well as age and sex of the patients. The laboratory values of the years 2017 and 2018 are included. There are no additional measurements on patients.
Detailed description
The laboratory values of the years 2017 and 2018 are included. All laboratory results to be evaluated originate from Medics Labor in Bern. We expect about 50'000 data sets. It is impossible for the study team to draw conclusions about the patients or the senders.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- no restriction
Key inclusion criteria (1 listed)
- all data sets available
Key exclusion criteria (1 listed)
- a declaration from the patient that his laboratory values may not be included in an evaluation.
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 |
|---|---|---|
| serum value 1,25(OH)2 vitamin DAlso: serum value 25(OH) vitamin D, serum value magnesium, serum value creatininestatistical evaluation of the serum values | Diagnostic test | – |
Primary outcome
correlation of serum values of 1,25(OH)2 vitamin D with estimated glomerular filtration rate
Time frame: 2017 - 2018
statistical evaluation of serum values
correlation of serum values of 1,25(OH)2 vitamin D with magnesium
Time frame: 2017 - 2018
statistical evaluation of serum values
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 11 Feb 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydroxylase Deficiency, run by University Hospital, Basel, Switzerland.
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 1 inclusion and 1 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 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
correlation of serum values of 1,25(OH)2 vitamin D with estimated glomerular filtration rate (time frame: 2017 - 2018). The study lists 2 primary outcomes in all. 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 11 Feb 2020.