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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Kidney Foundation, Singapore
Information provided by:
National University, Singapore
ClinicalTrials.gov Identifier:
NCT01102179
First received: April 12, 2010
Last updated: August 27, 2013
Last verified: August 2013
  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

Resource links provided by NLM:


Further study details as provided by National University, 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  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: August 27, 2013
Health Authority: Singapore: Health Sciences Authority

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

ClinicalTrials.gov processed this record on August 25, 2014