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Completed

NCT Number: NCT01102179

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

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National University Hospital

Singapore

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Vitamin D 25(OH)D levels

    Time frame: baseline

    Vitamin D levels are only measured at one time point i.e. at baseline

Sponsors and collaborators

Lead sponsor

National University of Singapore

Other

Collaborators

  • National Kidney Foundation, Singapore

Registry information

Official study title

Prevalence of Vitamin D Insufficiency and Deficiency in Chronic Kidney Disease Patients in Singapore

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Apr 13, 2010
Registry last updated
Nov 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.