Chronic Kidney Disease-Mineral and Bone DisorderNCT05399251
Relationship Between Serum 1,25-dihydroxy Vitamin D and Markers of Bone Metabolism in Renal Dysfunction Patients
An observational study of Chronic Kidney Disease-Mineral and Bone Disorder, run by Aga Khan University Hospital, Pakistan.
Trial summary
This cross-sectional study was conducted, including those subjects tested for 1,25(OH)2D during Jan 2015-Dec 2021. Estimated glomerular filtration rate (eGFR) was calculated and subjects were classified into chronic kidney disease (CKD) stages. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Chronic Kidney Disease-Mineral and Bone Disorder
- How many people
- 1,553 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 30 Dec 2021
- How long will I take part?
- 1 Year
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Laboratory data of patients tested for 1,25(OH)2D from January 2015 to December 2021 was retrieved from laboratory integrated systems (ILMS), and only the initial results for 1,25(OH)2D were included.
Who may be able to join
- Data of serum 1,25(OH)2D available
Who cannot join
- Serum1,25(OH)2D is not available
About this study
This cross-sectional study was conducted, including those subjects tested for 1,25(OH)2D during Jan 2015-Dec 2021. Estimated glomerular filtration rate (eGFR) was calculated and subjects were classified into chronic kidney disease (CKD) stages. Associations between biochemical marker, calcium, phosphorus, magnesium, alkaline phosphatase, 1,25(OH)2D and CKD stages was determined.
- Keywords
- renal dysfunction, bone metabolism marker, 1,25(OH)2 vitamin D
- Medical subject headings
- Chronic Kidney Disease-Mineral and Bone Disorder, Renal Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
concentration of serum 1,25 dihydroxy vitamin D in U/L in five stages of chronic kidney disease
In CKD, 1-alfa-hydroxylase activity in the kidneys is reduced, leading to decreases in the level of the activated form of vitamin D (1,25- dihydroxy vitamin D), resulting in secondary hyperparathyroidism and bone disease. This study aimed to determine the concentration of 1,25 dihydroxy vitamin D in different stages of CKD.
Measured: 7 year
concentration of serum calcium in mg/dl in five stages of chronic kidney disease
in renal tubules, 1,25- dihydroxy vitamin D increase reabsorption of calcium from renal filtrate and thus stabilize blood calcium levels. in CKD, with deterioration of kidney function, stage V, the levels of calcium drops resulting in hypocalcemia.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start1 Jan 2015
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease-Mineral and Bone DisorderStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,553 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Aga Khan University Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zaib Un Nisa Khan, Aga Khan University Hospital, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399251
- Sponsor's protocol ID
- ERC # 2020-3295-14097
- Status last verified
- May 2022
- First submitted
- 14 Feb 2022
- Last updated
- 1 Jun 2022
- 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 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Serum 1,25-dihydroxy Vitamin D and Markers of Bone Metabolism in Renal Dysfunction Patients
- ClinicalTrials.gov ID
- NCT05399251
- Acronym / sponsor ID
- ERC # 2020-3295-14097
- Keywords
- renal dysfunction, bone metabolism marker, 1,25(OH)2 vitamin D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,553 participants (actual)
- Lead sponsor
- Aga Khan University Hospital, PakistanUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 1 Jun 2022 (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.
This cross-sectional study was conducted, including those subjects tested for 1,25(OH)2D during Jan 2015-Dec 2021. Estimated glomerular filtration rate (eGFR) was calculated and subjects were classified into chronic kidney disease (CKD) stages. Associations between biochemical marker, calcium, phosphorus, magnesium, alkaline phosphatase, 1,25(OH)2D and CKD stages was determined.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Laboratory data of patients tested for 1,25(OH)2D from January 2015 to December 2021 was retrieved from laboratory integrated systems (ILMS), and only the initial results for 1,25(OH)2D were included.
Key inclusion criteria (1 listed)
- Data of serum 1,25(OH)2D available
Key exclusion criteria (1 listed)
- Serum1,25(OH)2D is not available
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
concentration of serum 1,25 dihydroxy vitamin D in U/L in five stages of chronic kidney disease
Time frame: 7 year
In CKD, 1-alfa-hydroxylase activity in the kidneys is reduced, leading to decreases in the level of the activated form of vitamin D (1,25- dihydroxy vitamin D), resulting in secondary hyperparathyroidism and bone disease. This study aimed to determine the concentration of 1,25 dihydroxy vitamin D in different stages of CKD.
concentration of serum calcium in mg/dl in five stages of chronic kidney disease
Time frame: 7 years
in renal tubules, 1,25- dihydroxy vitamin D increase reabsorption of calcium from renal filtrate and thus stabilize blood calcium levels. in CKD, with deterioration of kidney function, stage V, the levels of calcium drops resulting in hypocalcemia.
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 1 Jun 2022.
- 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 Chronic Kidney Disease-Mineral and Bone Disorder, run by Aga Khan University Hospital, Pakistan.
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 1 Jun 2022. 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?
concentration of serum 1,25 dihydroxy vitamin D in U/L in five stages of chronic kidney disease (time frame: 7 year). 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 1 Jun 2022.