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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency; End Stage Renal Disease
• Intervention / Treatment: Other: ergocalciferol supplementation; Other: dialysis techniques; Other: sunlight exposure time

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 Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand
    • Chulalongkorn Univeristy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Other: ergocalciferol supplementation; Participants in both groups will recieve ergocalciferol with different supplementation regimens for 6 months.; Other Names: nutritional vitamin D supplementation; Other: dialysis techniques; Both groups will have participants treated with maintenance hemodialysis and peritoneal dialysis.; Other Names: mode of dialysis; Other: sunlight exposure time; Both groups will be advised to receive similar hours of daily sunlight exposure time.
Experimental: Vitamin D supplementation using fixed dose regimen; Patients will receive ergocalciferol 20,000 unit orally per week for 6 months.	Other: ergocalciferol supplementation; Participants in both groups will recieve ergocalciferol with different supplementation regimens for 6 months.; Other Names: nutritional vitamin D supplementation; Other: dialysis techniques; Both groups will have participants treated with maintenance hemodialysis and peritoneal dialysis.; Other Names: mode of dialysis; Other: sunlight exposure time; Both groups will be advised to receive similar hours of daily sunlight exposure time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
proportion of patients with vitamin D adequacy	serum 25(OH)D more than 30 ng/ml	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum calcium	pre-dialysis serum calcium levels	6 months
serum phosphorus	pre-dialysis serum phosphorus levels	6 months
serum intact parathyroid hormone	pre-dialysis serum intact parathyroid hormone levels	6 months
muscle mass	bioimpedance-derived muscle mass measurement	6 months
muscle strength	handgrip strength measurement	6 months

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Investigators: Principal Investigator: Piyawan Kittiskulnam, Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: June 21, 2022
• First Submitted That Met QC Criteria: June 26, 2022
• First Posted (Actual): June 28, 2022

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: dialysis; ergocalciferol; vitamin D insufficiency
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Vitamin D Deficiency; Kidney Failure, Chronic; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Ergocalciferols
• Other Study ID Numbers: 326/65

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No