End Stage Renal Disease, Vitamin D Deficiency
Conditions
Keywords
vitamin D insufficiency, dialysis, ergocalciferol
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.
Interventions
Participants in both groups will recieve ergocalciferol with different supplementation regimens for 6 months.
OTHERdialysis techniques
Both groups will have participants treated with maintenance hemodialysis and peritoneal dialysis.
OTHERsunlight exposure time
Both groups will be advised to receive similar hours of daily sunlight exposure time.
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| proportion of patients with vitamin D adequacy | 6 months | serum 25(OH)D more than 30 ng/ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| serum calcium | 6 months | pre-dialysis serum calcium levels |
| serum phosphorus | 6 months | pre-dialysis serum phosphorus levels |
| serum intact parathyroid hormone | 6 months | pre-dialysis serum intact parathyroid hormone levels |
| muscle mass | 6 months | bioimpedance-derived muscle mass measurement |
| muscle strength | 6 months | handgrip strength measurement |
Countries
Thailand
Outcome results
None listed