Pussadee Hiranas. Efficacy of vitamin D2 and alfacalcidol supplementation on serum 25-hydroxyvitamin D level. Master's Degree(Anti-Aging and Regenerative Medicine). Mae Fah Luang University . : Mae Fah Luang University, 2014.
Efficacy of vitamin D2 and alfacalcidol supplementation on serum 25-hydroxyvitamin D level
Abstract:
Background: Low serum 25-hydroxyvitamin D level (25(OH)D) is associated with poor clinical outcomes including rickets in children, osteomalacia in adults, impaired immunity and possible increased cardiovascular and cancer risks.
Objectives: To compare the efficacy and safety between Vitamin D2 (Ergocalciferol) and Alfacalcidol (synthetic Vitamin D3 analog) in raising 25-hydroxyvitamin D level.
Methods: We conducted a prospective, single-center, simple randomized trial enrolling 60 adult patients to receive either Vitamin D2 20,000 IU weekly or Alfacalcidol 0.5 microgram once a day. Serum 25(OH)D, Calcium, BUN, Cr, SGOT, SGPT, ALP, Magnesium, Phospate, Uric acid were measured at baseline and 8 weeks later.
Results: After 8 weeks of treatment, patients in group A (Vitamin D2) had significant increase of serum 25 (OH)D level from the baseline 29.08 ± 8.26 vs 37.71 ± 10.70 ng/mL (p < 0.001). But patients in group B (Alfacalcidol) had no significant increase of serum 25(OH)D level from baseline 28.02 ± 8.03 vs 28.57 ± 8.43 ng/mL (p = 0.578). The patients in group A (Vitamin D2) had significant increase in serum 25(OH)D level (week 8-week 0) more than group B (Alfacalcidol) (group A : Median = 6.81ng/mL [23.18% increase from the baseline], Mean = 8.63 ng/mL [35.08% from the baseline] and group B : Median = 0 ng/mL [0%], Mean = 0.55 ng/ml [3.28% from the baseline] [p<0.001]).
There were no significant differences of serum calcium level between week 0 and week 8 of group A (Vitamin D2) (Mean at week 0 = 9.61 + 0.35 mg/dl [range 8.7-10.5 mg/dl], at week 8 = 9.50 + 0.43 mg/dl [range 8.8-11.1mg/dl]), and group B (Alfacalcidol) (Mean at week 0 = 9.44 + 0.39 mg/dl [range 8.8-10.4 mg/dl] , at week 8 = 9.11 + 1.61 mg/dl [range 8.6-10.3mg/dl]). After 8 weeks there was only one patient that had hypercalcemia in Vitamin D2 group with serum calcium 11.1mg/dl but without symptoms of hypercalcemia (hypercalcemia was defined by serum calcium >10.4 mg/dl). Before treatment at week 0, this patient also had high serum calcium at 10.5mg/dl.
Conclusions: Our study did show a significant increase of 25 (OH)D level on a Vitamin D2 dose of 20,000 IU/ week but not on the Alfacalcidol 0.5 microgram/ day. There was no increased risk of hypercalcemia in the treatment doses in both groups.