Comparative Effectiveness of Vitamin D and Repletion Strategies
Condition: Hypovitaminosis D; Insulin Resistance; Diabetes
MeSH terms: Rickets; Insulin Resistance; Avitaminosis; Vitamin D Deficiency
Study type: Interventional

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.
    

Detailed description: 
      VitD has numerous hormonal effects, including regulation of Ca2+ and Mg2+, as well as effects
      on numerous genes, including insulin and androgens. Mounting literature demonstrates
      associations between VitD insufficiency and cancer, diabetes and heart disease. VitD
      insufficiency, defined by concentration of serum 25-hydroxycholecalciferol (25-OHD) <33ng/ml
      (82.5 nmol/ml), is common at all latitudes; the prevalence is estimated at ~35% in "healthy"
      populations. VitD testing and replacement is gaining popularity in clinical practice. It is
      not known whether there is a difference in the effect of equivalent doses of emulsified vs.
      non-emulsified cholecalciferol (VitD3) supplementation, reflected by quantitative changes in
      serum 25-OHD. However, clinical observations revealed that in an average of 4.4 months,
      subjects taking 4000 iu daily of the emulsified form of cholecalciferol improved their 25-OHD
      levels by 6.76 ng/mL more than those taking 5,000 iu daily of the non-emulsified form. The
      safety of taking 10,000 IU/day has been confirmed. Taking this dose for 12 weeks should cause
      a robust increase in serum 25-OHD. This study will provide preliminary data comparing three
      high quality VitD3 supplements, one a powdered capsule, one a chewable tablet, and the other
      a lipid-emulsified liquid. Future studies will compare the "better" supplement to
      conventional VitD replacement using VitD2.
    

Intervention name(s): Vitamin D3; Vitamin D3; Vitamin D3
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 10,000 IU per Day for 12 Weeks; 10,000 IU per Day for 12 Weeks; 10,000 IU per Day for 12 Weeks
Other intervention name(s): Calcitriol; Calcitriol; Calcitriol
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Calcitriol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: vitamin d; cholecalciferol; nutritional supplements; hypovitaminosis d; klotho; toll like receptor 4