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

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ClinicalTrials.gov Identifier: NCT01102179
Recruitment Status : Completed
First Posted : April 13, 2010
Last Update Posted : November 7, 2014
Sponsor:
Collaborator:
National Kidney Foundation, Singapore
Information provided by:
National University, Singapore

Brief 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). 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 or disease
Stage 2-5 Chronic Kidney Disease Predialysis

Study Type : Observational
Actual Enrollment : 196 participants
Time Perspective: Cross-Sectional
Official Title: Prevalence of Vitamin D Insufficiency and Deficiency in Chronic Kidney Disease Patients in Singapore
Study Start Date : April 2010
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D
U.S. FDA Resources

Group/Cohort
Chronic kidney disease

All patients with stage 2-5 (pre-dialysis) chronic kidney disease

One-time blood draw (10 ml)




Primary Outcome Measures :
  1. Vitamin D 25(OH)D levels [ Time Frame: baseline ]
    Vitamin D levels are only measured at one time point i.e. at baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with stage 2-5 chronic kidney disease who are not on dialysis
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01102179


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

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
First Posted: April 13, 2010    Key Record Dates
Last Update Posted: November 7, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Vitamin D
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents