A Randomized Study Using Three Vitamin D3 Formulations to Assess 25-Hydroxy Vitamin D and Calcium Levels after 8-Week Treatment Period

Abstract

Background: Vitamin D has a vital role in bone metabolism and promotes the absorption of calcium in the intestine. Thus, adequate level of vitamin D is of critical importance. Methods: A prospective, randomized, comparative, open-label, parallel-group study evaluated the efficacy, safety and tolerability of three Vitamin D3 products in patients with vitamin D3 deficiency or insufficiency. These products included soft gelatin capsule, granules, and chewable tablet. The dosing regimen was once a week for eight weeks. Change in levels of 25-hydroxyvitamin D and calcium were analyzed. Results: The change in 25-hydroxyvitamin D levels from baseline to week 8, and the results of paired t-test indicated statistically significant rise in 25-hydroxyvitamin D levels in each group. The mean percentage improvement in 25-hydroxyvitamin D was in the order: chewable tablet>capsule>granules. The chewable tablet showed an additional important benefit of highest rise in calcium levels, and the rise was in the order: chewable tablet>capsule>granules. Furthermore, no adverse event was noted in any group. Conclusion: The efficacy of the chewable tablet in improving both 25-hydroxyvitamin D and calcium levels along with the cost-effectiveness, ease of use, and palatability makes it an attractive choice over other oral formulations in treatment of patients with 25-hydroxyvitamin D insufficiency or deficiency.