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A Randomized Study Comparing Between Fixed Dose and Serum Level-Based Titration Regimen of Vitamin D Supplementation Among Dialysis Patients
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.
The investigators plan to conduct a randomized study comparing the two different protocols between serum 25(OH)D level-based titration regimen and fixed dose of ergocalciferol supplementation among dialysis patients for a total period of 6 months. At the study completion, investigators also plan to compare the proportion of participants achieving serum 25(OH)D of more than 30 ng/ml, CKD-related metabolic and bone parameters as well as non-skeletal effect of vitamin D supplementation for each group.
Age
18 - 100 years
Sex
ALL
Healthy Volunteers
No
Chulalongkorn Univeristy
Bangkok, Thailand
Start Date
August 1, 2022
Primary Completion Date
May 31, 2023
Completion Date
December 31, 2023
Last Updated
February 8, 2024
78
ACTUAL participants
ergocalciferol supplementation
OTHER
dialysis techniques
OTHER
sunlight exposure time
OTHER
Lead Sponsor
Chulalongkorn University
NCT07146854
NCT04163614
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT04580420