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

Not Applicable

Completed

• Conditions: Vitamin D Deficiency; End Stage Renal Disease
• Interventions: Other: ergocalciferol supplementation; Other: dialysis techniques; Other: sunlight exposure time

• Registration Number: NCT05434377
• Lead Sponsor: Chulalongkorn University

Brief 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.

Study Timeline

• Study First Submitted: 2022-06-21
• Study First Submitted QC: 2022-06-26
• Study First Posted: 2022-06-28
• Study Start: 2022-08-01
• Primary Completion: 2023-05-31
• Study Completion: 2023-12-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

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

Exclusion Criteria

• current ergocalciferol or cholecalciferol treatment
• known allergy to ergocalciferol
• active inflammation or infection
• advanced stage of cancer
• pregnancy
• lactation
• on immunosuppressive drugs or corticosteroids

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D supplementation using titration regimen	dialysis techniques	Patients will receive ergocalciferol orally depending on serum 25(OH)D level as described * serum 25(OH)D \< 5 ng/ml --\> receive ergocalciferol 50,000 IU/week for 3 months followed by 50,000 IU monthly for 3 months * serum 25(OH)D 5-15 ng/ml--\> receive ergocalciferol 50,000 IU/week for 1 month followed by 50,000 IU monthly for 5 months * serum 25(OH)D 16-30 ng/ml--\> receive ergocalciferol 50,000 IU monthly for 6 months
Vitamin D supplementation using fixed dose regimen	dialysis techniques	Patients will receive ergocalciferol 20,000 unit orally per week for 6 months.
Vitamin D supplementation using titration regimen	ergocalciferol supplementation	Patients will receive ergocalciferol orally depending on serum 25(OH)D level as described * serum 25(OH)D \< 5 ng/ml --\> receive ergocalciferol 50,000 IU/week for 3 months followed by 50,000 IU monthly for 3 months * serum 25(OH)D 5-15 ng/ml--\> receive ergocalciferol 50,000 IU/week for 1 month followed by 50,000 IU monthly for 5 months * serum 25(OH)D 16-30 ng/ml--\> receive ergocalciferol 50,000 IU monthly for 6 months
Vitamin D supplementation using fixed dose regimen	sunlight exposure time	Patients will receive ergocalciferol 20,000 unit orally per week for 6 months.
Vitamin D supplementation using fixed dose regimen	ergocalciferol supplementation	Patients will receive ergocalciferol 20,000 unit orally per week for 6 months.
Vitamin D supplementation using titration regimen	sunlight exposure time	Patients will receive ergocalciferol orally depending on serum 25(OH)D level as described * serum 25(OH)D \< 5 ng/ml --\> receive ergocalciferol 50,000 IU/week for 3 months followed by 50,000 IU monthly for 3 months * serum 25(OH)D 5-15 ng/ml--\> receive ergocalciferol 50,000 IU/week for 1 month followed by 50,000 IU monthly for 5 months * serum 25(OH)D 16-30 ng/ml--\> receive ergocalciferol 50,000 IU monthly for 6 months

Primary Outcome Measures

Name	Time	Method
proportion of patients with vitamin D adequacy	6 months	serum 25(OH)D more than 30 ng/ml

Secondary Outcome Measures

Name	Time	Method
serum intact parathyroid hormone	6 months	pre-dialysis serum intact parathyroid hormone levels
serum calcium	6 months	pre-dialysis serum calcium levels
muscle mass	6 months	bioimpedance-derived muscle mass measurement
serum phosphorus	6 months	pre-dialysis serum phosphorus levels
muscle strength	6 months	handgrip strength measurement

Trial Locations

Locations (1)

Chulalongkorn Univeristy; 🇹🇭 Bangkok, Thailand