Comparative Effectiveness of Vitamin D and Repletion Strategies

Study Summary

The importance of vitamin D (VitD) in the prevention and treatment of human health conditions has gained increased attention in recent years. As a result, medical providers of all categories are screening clinical VitD status frequently, yet become challenged with how to best advise patients regarding repletion of VitD status, i.e. which form of VitD replacement is most effective. It has been recognized that to achieve significant effects - serum concentrations \>30ng/ml (75 nmol/ml) - it is necessary, as well as safe, to recommend substantially higher doses than were previously thought sufficient. These higher doses can be easily achieved orally. This clinical trial aims to compare absorption of three available forms of this fat-soluble vitamin, due to the potential differences in absorption of different preparations. High-quality powdered, chewable and lipid-emulsified VitD are readily available as supplements, yet these have not been systematically compared. This three-arm, randomized clinical trial will compare the difference in serum 25-hydroxycholecalciferol (25-OH)D concentration between the three arms at baseline and after random administration of one of the three VitD preparations for 12-weeks at a dosage of 10,000 IU VitD per day. The investigators hypothesize that the three forms of vitD will result in an equivalent increase in serum 25OHD.

Primary Outcome

To compare the change in serum 25-hydroxycholecalciferol (25-OHD) concentration between three forms of supplemental vitamin D3: a lipid-emulsified form administered in a sesame oil base, a non-emulsified chewable tablet, and a non-emulsified form administered as a capsule, following 12 weeks of supplementation (10,000 IU/day) in D3 insufficient patients (baseline 25-OHD \<33ng/ml (82.5 nmol/ml)) patients.

Interventions

• DIETARY_SUPPLEMENT Vitamin D3