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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
78
Participants in both groups will recieve ergocalciferol with different supplementation regimens for 6 months.
Both groups will have participants treated with maintenance hemodialysis and peritoneal dialysis.
Both groups will be advised to receive similar hours of daily sunlight exposure time.
Chulalongkorn Univeristy
Bangkok, Thailand
proportion of patients with vitamin D adequacy
serum 25(OH)D more than 30 ng/ml
Time frame: 6 months
serum calcium
pre-dialysis serum calcium levels
Time frame: 6 months
serum phosphorus
pre-dialysis serum phosphorus levels
Time frame: 6 months
serum intact parathyroid hormone
pre-dialysis serum intact parathyroid hormone levels
Time frame: 6 months
muscle mass
bioimpedance-derived muscle mass measurement
Time frame: 6 months
muscle strength
handgrip strength measurement
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.