Treatment of Vitamin D Deficiency With Large Bolus Cholecalciferol

Study Overview
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Brief Summary
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Comparing two treatment regimens (solitary large dose vs daily smaller dose) in patients diagnosed with vitamin D deficiency.

Detailed Description
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Study is looking at patients with diagnosed vitamin D deficiency (<20ng/mL). Participants are healthy adults between 18 and 75. No diagnosis of cancer, pregnancy, hypercalcemia, hyperparathyroidism, gastrointestinal absorption disorder, or chronic kidney disease and not taking medications for seizures or osteoporosis. Participants are randomized into two treatment groups: (1) 5,000IU cholecalciferol daily or (2) one-time 300,000 international units (IU) cholecalciferol. Vitamin D level, calcium level, and renal function are measure one week after initiating treatment and then at 3 months, 6 months, 9 months, and 12 months.

Official Title
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Treatment of Vitamin D Deficiency With Large Bolus Cholecalciferol in the Outpatient Setting

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Drug: Cholecalciferol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-75yrs old serum 25(OH)-vitamin D level <20ng/mL patient of Parkview Adult Medicine clinic not currently on cholecalciferol >2,000IU daily no ergocalciferol administration within last week Exclusion Criteria: history of hypercalcemia or hyperparathyroidism history of chronic kidney disease with baseline creatinine >1.1 history of gastric absorption abnormalities history of Paget's disease or osteomalacia history of thyrotoxicosis known malignancy currently pregnant taking medications for osteoporosis or seizures taking more than 1200mg/day of calcium inpatient hospitalization at the initiation of study meds

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Large bolus<br> | Drug: Cholecalciferol<br>* Large, one time dose of 300,000 IU oral cholecalciferol or daily 5,000 IU oral cholecalciferol<br>|
| Active Comparator: Standard<br> | Drug: Cholecalciferol<br>* Large, one time dose of 300,000 IU oral cholecalciferol or daily 5,000 IU oral cholecalciferol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of treatment of vitamin D deficiency over a one year time frame: normalization of vitamin D levels above 30ng/mL | Looking for normalization of vitamin D levels | 12months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of efficacy after starting vitamin D replacement as monitored at one week and then three month intervals for one year | Evaluation of how long participants maintain normal vitamin D levels with treatment | 1 week, 3 months, 6 months, 9 months, 12 months | 
| Compliance with therapy as measured by the reported number of missed doses at one week on therapy and then every three months for a year | Evaluation of missed doses | 1 week, 3 months, 6 months, 9 months, 12 months |