NCT05434377

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Chulalongkorn University · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Vitamin D Deficiency
• End Stage Renal Disease

Interventions

Type	Name	Description
OTHER	ergocalciferol supplementation	Participants in both groups will recieve ergocalciferol with different supplementation regimens for 6 months.
OTHER	dialysis techniques	Both groups will have participants treated with maintenance hemodialysis and peritoneal dialysis.
OTHER	sunlight exposure time	Both groups will be advised to receive similar hours of daily sunlight exposure time.

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-05-31
• Completion: 2023-12-31
• First posted: 2022-06-28
• Last updated: 2024-02-08

Locations

1 site across 1 country: Thailand