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

NCT ID: NCT05434377

Last Updated: 2024-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2023-12-31

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.

Conditions

Vitamin D Deficiency; End Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Vitamin D supplementation using titration regimen

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

Group Type: ACTIVE_COMPARATOR

ergocalciferol supplementation

Intervention Type: OTHER

Participants in both groups will recieve ergocalciferol with different supplementation regimens for 6 months.

dialysis techniques

Intervention Type: OTHER

Both groups will have participants treated with maintenance hemodialysis and peritoneal dialysis.

sunlight exposure time

Intervention Type: OTHER

Both groups will be advised to receive similar hours of daily sunlight exposure time.

Vitamin D supplementation using fixed dose regimen

Patients will receive ergocalciferol 20,000 unit orally per week for 6 months.

Group Type: EXPERIMENTAL

ergocalciferol supplementation

Intervention Type: OTHER

Participants in both groups will recieve ergocalciferol with different supplementation regimens for 6 months.

dialysis techniques

Intervention Type: OTHER

Both groups will have participants treated with maintenance hemodialysis and peritoneal dialysis.

sunlight exposure time

Intervention Type: OTHER

Both groups will be advised to receive similar hours of daily sunlight exposure time.

Interventions

ergocalciferol supplementation

Participants in both groups will recieve ergocalciferol with different supplementation regimens for 6 months.

Intervention Type: OTHER

dialysis techniques

Both groups will have participants treated with maintenance hemodialysis and peritoneal dialysis.

Intervention Type: OTHER

sunlight exposure time

Both groups will be advised to receive similar hours of daily sunlight exposure time.

Intervention Type: OTHER

Other Intervention Names

nutritional vitamin D supplementation; mode of dialysis

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chulalongkorn University

OTHER

Sponsor Role: lead

Responsible Party

Piyawan Kittiskulnam

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Piyawan Kittiskulnam

Role: PRINCIPAL_INVESTIGATOR

Chulalongkorn University

Locations

Chulalongkorn Univeristy

Bangkok, , Thailand

Countries

Thailand

Other Identifiers

326/65

Identifier Type: -

Identifier Source: org_study_id