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NCT05434377

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

Completed NA Last updated 8 February 2024
What this trial tests

NA trial testing ergocalciferol supplementation in Vitamin D Deficiency in 78 participants. Completed in 31 December 2023.

Timeline
1 August 2022
Primary endpoint
31 May 2023
31 December 2023

Quick facts

Lead sponsorChulalongkorn University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment78
Start date1 August 2022
Primary completion31 May 2023
Estimated completion31 December 2023
Sites1 location across Thailand

Drugs / interventions tested

Conditions studied

Sponsor

Chulalongkorn University

Who can join

Adults 18 to 100, any sex, with Vitamin D Deficiency or End Stage Renal Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Sarcopenia in chronic kidney disease: from bench to bedside.
    Kim DW, Song SH. · · 2023 · cited 18× · PMID 37077132 · DOI 10.3904/kjim.2022.338
  2. Clinical features and molecular mechanism of muscle wasting in end stage renal disease.
    Ju SH, Yi HS. · · 2023 · cited 5× · PMID 37482754

Verify or expand the search:

Other recruiting trials for Vitamin D Deficiency

Currently open trials in the same condition.

Other Chulalongkorn University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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