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

Chulalongkorn University

Status: Completed

Conditions: Vitamin D Deficiency; End Stage Renal Disease

Treatments: Other: dialysis techniques; Other: ergocalciferol supplementation; Other: sunlight exposure time

Study type: Interventional

Funder types: Other

Identifiers

NCT05434377

326/65

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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78 participants in 2 patient groups

Vitamin D supplementation using titration regimen

Active Comparator group

Description:

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

Treatment:

Other: sunlight exposure time

Other: ergocalciferol supplementation

Other: dialysis techniques

Vitamin D supplementation using fixed dose regimen

Experimental group

Description:

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

Treatment:

Other: sunlight exposure time

Other: ergocalciferol supplementation

Other: dialysis techniques