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

Vitamin D Deficiency Clinical Trial

Official title:

A Randomized Study Comparing Between Fixed Dose and Serum Level-Based Titration Regimen of Vitamin D Supplementation Among Dialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05434377
• Other study ID #: 326/65
• Status: Completed
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: December 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic
• Vitamin D Deficiency

Intervention

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

Locations

Country	Name	City	State
Thailand	Chulalongkorn Univeristy	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of patients with vitamin D adequacy	serum 25(OH)D more than 30 ng/ml	6 months
Secondary	serum calcium	pre-dialysis serum calcium levels	6 months
Secondary	serum phosphorus	pre-dialysis serum phosphorus levels	6 months
Secondary	serum intact parathyroid hormone	pre-dialysis serum intact parathyroid hormone levels	6 months
Secondary	muscle mass	bioimpedance-derived muscle mass measurement	6 months
Secondary	muscle strength	handgrip strength measurement	6 months