Effects of Vitamin D3 Versus 25OHD3 on Mineral Metabolism and Immune Function

Study Overview
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Brief Summary
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The purpose of this study is to compare the effects of two different forms of vitamin D supplements (vitamin D3 and 25-hyrdroxyvitamin D3 [25(OH)D3]) on vitamin D levels in the blood, and on markers of skeletal and immune health. This study is designed as a pilot study. A multi-ethnic cohort of 48 patients will be included (12 Caucasian, 12 African American, 12 Hispanic/Latino, 12 Asian/Asian American). Potential study candidates will undergo a screening visit during which a medical history will be taken, a physical exam performed, a dietary questionnaire administered, and blood collected. The purpose of the screening visit is to identify vitamin D-deficient (25-hydroxyvitamin D <20 ng/ml) individuals who are candidates for vitamin D supplementation. Eligible patients will then be randomly assigned to receive either vitamin D3 (2400 IU/day) or 25(OH)D3 (20 mcg/day) for 16 weeks. After initiating supplementation, study patients will return for follow-up visits at weeks 4, 8, and 16. At each visit, blood will be collected to assess vitamin D levels in the blood, as well as markers of skeletal and immune function. Participation in this study will therefore involve a total of 5 visits (1 screening visit, 1 randomization visit during which participants will receive their study supplements, 3 follow-up visits). After all data is collected, changes in vitamin D levels in the blood following supplementation with either vitamin D3 versus 25(OH)D3 will be determined, and correlated to markers of calcium balance and immune function. Knowledge gained from this study may have a significant impact on how vitamin D status is defined, and how vitamin D repletion is administered.

Official Title
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The Effects of Vitamin D3 Versus 25OHD3 (HyD) on Serum Vitamin D Metabolites and Markers of Mineral Metabolism and Immune Function

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Drug: Vitamin D
* Drug: 25(OH)D3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 25D < 20 mg/ml Exclusion Criteria: Age < 18 25D > 20 ng/ml at time of screening Clear signs of infection at time of screening (coughing, sneezing, wheezing, frequency, dysuria) History of conditions that would influence intestinal absorption of vitamin D3 or 25OHD3 supplements History of nephrolithiasis, primary hyperparathyroidism, or other metabolic bone disease History of chronic kidney disease (defined as CrCl < 30 ml/min) History of rheumatologic or autoimmune conditions History of sarcoidosis History of active or latent tuberculosis History of HIV History of hyperthyroidism History of chronic glucocorticoid use defined as the equivalent of 5 mg of prednisone per day for more than 2 months within the last 6 months History of use of medications known to affect calcium/vitamin D metabolism, bone metabolism, and immune response Hypercalcemia Hypercalcinuria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 25(OH)D3<br>20 micrograms/day by mouth for 16 weeks | Drug: 25(OH)D3<br>* 20 micrograms/day by mouth for 16 weeks<br>* Other names: HyD;|
| Experimental: Vitamin D3<br>2,400 IU/day by mouth for 16 weeks | Drug: Vitamin D<br>* 2400 IU/day by mouth for 16 weeks<br>* Other names: Cholecalciferol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total serum 25D |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum free 25D |  | 16 weeks | 
| Change in serum total 1,25D |  | 16 weeks | 
| Change in total free 1,25D |  | 16 weeks | 
| Change in serum calcium |  | 16 weeks | 
| Change in urinary calcium |  | 16 weeks | 
| Change in serum iPTH |  | 16 weeks | 
| Change in serum bone turnover markers |  | 16 weeks | 
| Change in markers of immune function |  | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypovitaminosis D, Free 25-hydroxyvitamin D, Total 25-hydroxyvitamin D