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NCT05434377Completed

A Study of Fixed Dose Versus Serum Level-Based Titration Regimen of Vitamin D Supplementation in Dialysis Patients

A Randomized Study Comparing Between Fixed Dose and Serum Level-Based Titration Regimen of Vitamin D Supplementation Among Dialysis Patients

Source: ClinicalTrials.gov · Last updated 8 Feb 2024

Brief summary (registry, in English)

Vitamin D insufficiency, defined as serum 25-hydroxyvitamin (OH) D level less than 30 ng/ml, is highly prevalent not only in the general population but also in chronic kidney disease (CKD) population. Many guidelines including the National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (NKF-KDOQI) have consistently recommended vitamin D supplementation in patients with pre-dialysis CKD with vitamin D insufficiency with ergocalciferol or cholecalciferol to achieve 25(OH)D level of more than 30 ng/ml using serum levels-based titration regimen. However, this protocol has not been studied in end stage kidney disease patients treated with maintenance dialysis.

Status (registry)
Completed
Study type
Interventional
Enrollment
78 (actual)
First submitted
21 Jun 2022
Start date
1 Aug 2022
Primary completion date
31 May 2023
Lead sponsor
Chulalongkorn University
NCT number
NCT05434377

What you commit to

  • Study type: Interventional
  • Participants enrolled: 78
  • From 1 Aug 2022 to the primary completion date, 31 May 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • on immunosuppressive drugs or corticosteroids

Other illness

  • known allergy to ergocalciferol
  • active inflammation or infection
  • advanced stage of cancer

Other

  • current ergocalciferol or cholecalciferol treatment
  • pregnancy
  • lactation

Who the study is looking for

  • age \> 18 years
  • on maintenance dialysis (hemodialysis or peritoneal dialysis) \> 3 months
  • 25(OH)D \< 30 ng/ml
  • able to provide inform consent form

Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chulalongkorn Univeristy
Coordinator of this site? Confirm its status
BangkokThailandUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.