Stage 2-5 Chronic Kidney DiseaseNCT01102179
Vitamin D Insufficiency and Deficiency in Chronic Kidney Disease (CKD) Patients in Singapore
An observational study of Stage 2-5 Chronic Kidney Disease and Predialysis, run by National University of Singapore at 1 site in Singapore.
Trial summary
Vitamin D insufficiency and deficiency is common in chronic kidney disease (CKD) patients and is associated with elevated parathyroid hormone (PTH) concentration and mineral and bone disorder (MBD). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stage 2-5 Chronic Kidney Disease, Predialysis
- How many people
- 196 participants
- Where
- 1 siteSingapore
- Study dates
- Apr 2010to Jul 2014
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stage 2-5 chronic kidney disease who are not on dialysis
Who may be able to join
- Male or female 21 years of age or older
- CKD stage 2 to 5 (who are not on dialysis): CKD stage 2: eGFR 60-89ml/min/1.73m2, stage 3: eGFR 30-59ml/min/1.73m2, stage 4: eGFR 15-29 ml/min/1.73m2, stage 5 eGFR <15 ml/min/1.73m2)
- Not receiving over-the-counter or prescription vitamin D therapy
- On a stable dose of phosphate binder (if any) for at least 1 month prior to the study
Who cannot join
- History of liver and chronic inflammatory diseases, primary hyperparathyroidism and malignancies
- Use of corticosteroids, anticonvulsants or vitamin D compounds
- Use of an investigational agent within 30 days of study entry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Vitamin D Insufficiency and Deficiency in Chronic Kidney Disease Patients in Singapore
Vitamin D insufficiency and deficiency is common in chronic kidney disease (CKD) patients and is associated with elevated parathyroid hormone (PTH) concentration and mineral and bone disorder (MBD). There is also increasing evidence to show that these abnormalities increase cardiovascular morbidity and mortality in CKD patients. There is a need for early identification of vitamin D insufficiency/deficiency in CKD patients to prevent its long-term complications. However, the vitamin D status of CKD patients in Singapore has not been well described. The purpose of this study is to assess the vitamin D status of predialysis CKD patients in a tertiary academic teaching hospital in Singapore, and its association with parameters for MBD. Predialysis patients from the outpatient renal clinic at the National University Hospital (NUH) will be recruited into this study. Blood samples from the patients will be collected after an overnight fast to determine their serum 25(OH)D, creatinine, phosphorus, calcium, albumin and i-PTH concentrations. These parameters will be compared among patients in various stages of CKD.
- Conditions
- Stage 2-5 Chronic Kidney Disease, Predialysis
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 |
|---|---|---|
| Chronic kidney disease | All patients with stage 2-5 (pre-dialysis) chronic kidney disease One-time blood draw (10 ml) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D 25(OH)D levels
Vitamin D levels are only measured at one time point i.e. at baseline
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage 2-5 Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe 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
- Time perspective
- Cross-sectional
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National Kidney Foundation, Singapore
- Investigators
- Priscilla P How, Pharm.D., Principal investigator, National University of Singapore/National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102179
- Sponsor's protocol ID
- DSRB Domain E/09/643
- Status last verified
- Oct 2014
- First submitted
- 12 Apr 2010
- Last updated
- 7 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Vitamin D Insufficiency and Deficiency in Chronic Kidney Disease Patients in Singapore
- ClinicalTrials.gov ID
- NCT01102179
- Acronym / sponsor ID
- DSRB Domain E/09/643
- Conditions
- Stage 2-5 Chronic Kidney Disease, Predialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- National Kidney Foundation, Singapore
- Study start
- Apr 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 13 Apr 2010 (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.
Vitamin D insufficiency and deficiency is common in chronic kidney disease (CKD) patients and is associated with elevated parathyroid hormone (PTH) concentration and mineral and bone disorder (MBD). There is also increasing evidence to show that these abnormalities increase cardiovascular morbidity and mortality in CKD patients. There is a need for early identification of vitamin D insufficiency/deficiency in CKD patients to prevent its long-term complications. However, the vitamin D status of CKD patients in Singapore has not been well described. The purpose of this study is to assess the vitamin D status of predialysis CKD patients in a tertiary academic teaching hospital in Singapore, and its association with parameters for MBD. Predialysis patients from the outpatient renal clinic at the National University Hospital (NUH) will be recruited into this study. Blood samples from the patients will be collected after an overnight fast to determine their serum 25(OH)D, creatinine, phosphorus, calcium, albumin and i-PTH concentrations. These parameters will be compared among patients in various stages of CKD.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic kidney disease | – | –All patients with stage 2-5 (pre-dialysis) chronic kidney disease One-time blood draw (10 ml) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stage 2-5 chronic kidney disease who are not on dialysis
Key inclusion criteria (4 listed)
- Male or female 21 years of age or older
- CKD stage 2 to 5 (who are not on dialysis): CKD stage 2: eGFR 60-89ml/min/1.73m2, stage 3: eGFR 30-59ml/min/1.73m2, stage 4: eGFR 15-29 ml/min/1.73m2, stage 5 eGFR <15 ml/min/1.73m2)
- Not receiving over-the-counter or prescription vitamin D therapy
- On a stable dose of phosphate binder (if any) for at least 1 month prior to the study
Key exclusion criteria (3 listed)
- History of liver and chronic inflammatory diseases, primary hyperparathyroidism and malignancies
- Use of corticosteroids, anticonvulsants or vitamin D compounds
- Use of an investigational agent within 30 days of study entry
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
Vitamin D 25(OH)D levels
Time frame: baseline
Vitamin D levels are only measured at one time point i.e. at baseline
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 7 Nov 2014.
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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.
Priscilla P How, Pharm.D. principal investigator
National University of Singapore/National University 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 Stage 2-5 Chronic Kidney Disease and Predialysis, run by National University of Singapore at 1 site in Singapore.
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 4 inclusion and 3 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 7 Nov 2014. 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 Singapore. 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?
Vitamin D 25(OH)D levels (time frame: baseline). 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 7 Nov 2014.