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. 2019 Oct 22;2019(10):CD005015. doi: 10.1002/14651858.CD005015.pub4

NCT00748618.

Trial name or title Vitamin D replacement after kidney transplant
Methods
  • Country: USA

  • Study design: single‐blind, parallel RCT

  • Duration of follow‐up: 6 months

Participants
  • Inclusion criteria: kidney transplant more than 6 months ago; 19 years or older; 25‐OH vitamin D ≤ 30 ng/mL

  • Exclusion criteria: eGFR < 30 mL/min/1.73m2; previous small bowel or lung transplant; pancreas transplant less than 6 months ago; cancer or any condition that would change their weight dramatically in the near future such as malabsorption; willing to return for testing every two months; women who are pregnant or < 6 weeks postpartum; hypercalcaemia; hyperphosphataemia; taking 10,000 IU or more of vitamin D per week; drinking more than 2 alcohol drinks a day or 14 drinks per week; history of parathyroid surgery; known granulomatous disease; hypomagnesaemia; taking any seizure medication that affects vitamin D; taking Zempler® and/or Rocaltro ®; history of kidney stones; not on a stable dose of bisphosphonate for the past 3 months; planning on a pancreas transplant within the next year; in any other research study

Interventions Treatment group
  • Vitamin D3 (oral) 50,000 IU/week for 6 months


Control group
  • Vitamin D3 (oral): 10,000 IU/week for 6 months


Co‐interventions
  • Not reported

Outcomes
  • Compare efficacy and safety of two vitamin D supplements of these doses in normalizing vitamin D concentrations

  • The ability of vitamin D to reduce PTH or change markers of vascular risk, insulin resistance, and/or inflammation, as well as its effect on urine calcium excretion

Starting date September 2008
Contact information Jillian M Witte: jmwitte@unmc.edu
Terica L Hudson: thudson@unmc.edu
Notes Recruitment status of the study is unknown because the information has not been verified recently. The Principal investigator, Professor Larsen (jlarsen@unmc.edu) has been contacted to request an update on the status of this study. No reply has been received. The contact information for other investigators described on the clinicaltrials.gov registry are no longer valid