Vitamin D Insufficiency and Deficiency in Chronic Kidney Disease (CKD) Patients in Singapore
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Purpose
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.
| Condition |
|---|
|
Stage 2-5 Chronic Kidney Disease Predialysis |
| Study Type: | Observational |
| Study Design: | Time Perspective: Cross-Sectional |
| Official Title: | Prevalence of Vitamin D Insufficiency and Deficiency in Chronic Kidney Disease Patients in Singapore |
| Estimated Enrollment: | 200 |
| Study Start Date: | April 2010 |
| Groups/Cohorts |
|---|
|
Chronic kidney disease
All patients with stage 2-5 (pre-dialysis) chronic kidney disease One-time blood draw (10 ml) |
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with stage 2-5 chronic kidney disease who are not on dialysis
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations| Contact: Priscilla P How, Pharm.D., BCPS | 65-6516-4906 | priscillahow@nus.edu.sg |
| Singapore | |
| National University Hospital | Recruiting |
| Singapore, Singapore | |
| Contact: Priscilla P How, Pharm.D., BCPS 65-6516-4906 priscillahow@nus.edu.sg | |
| Principal Investigator: Priscilla P How, Pharm.D., BCPS | |
| Principal Investigator: | Priscilla P How, Pharm.D. | National University of Singapore/National University Hospital |
More Information
No publications provided
| Responsible Party: | Dr. Priscilla How, National University Singapore/National University Hospital |
| ClinicalTrials.gov Identifier: | NCT01102179 History of Changes |
| Other Study ID Numbers: | DSRB Domain E/09/643 |
| Study First Received: | April 12, 2010 |
| Last Updated: | May 2, 2012 |
| Health Authority: | Singapore: Health Sciences Authority |
Additional relevant MeSH terms:
|
Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Urologic Diseases Renal Insufficiency Vitamin D |
Vitamins Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on June 17, 2013