Vitamin D Insufficiency and Deficiency in Chronic Kidney Disease (CKD) Patients in Singapore

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.

Study Overview

• Status: Completed
• Conditions: Stage 2-5 Chronic Kidney Disease; Predialysis

• Study Type: Observational
• Enrollment (Actual): 196

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with stage 2-5 chronic kidney disease who are not on dialysis

Description

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

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Chronic kidney disease; All patients with stage 2-5 (pre-dialysis) chronic kidney disease One-time blood draw (10 ml)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vitamin D 25(OH)D levels	Vitamin D levels are only measured at one time point i.e. at baseline	baseline

Collaborators and Investigators

• Sponsor: National University, Singapore
• Collaborators: National Kidney Foundation, Singapore
• Investigators: Principal Investigator: Priscilla P How, Pharm.D., National University of Singapore/National University Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: April 12, 2010
• First Submitted That Met QC Criteria: April 12, 2010
• First Posted (Estimate): April 13, 2010

Study Record Updates

• Last Update Posted (Estimate): November 7, 2014
• Last Update Submitted That Met QC Criteria: November 6, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: DSRB Domain E/09/643

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No