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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Vitamin D Deficiency, End Stage Renal Disease

Intervention / Treatment
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* Other: ergocalciferol supplementation
* Other: dialysis techniques
* Other: sunlight exposure time


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin D insufficiency, dialysis, ergocalciferol