Vitamin D Deficiency
Conditions
Brief summary
Comparing two treatment regimens (solitary large dose vs daily smaller dose) in patients diagnosed with vitamin D deficiency.
Detailed description
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.
Interventions
DRUGCholecalciferol
Large, one time dose of 300,000 IU oral cholecalciferol or daily 5,000 IU oral cholecalciferol
Sponsors
Parkview Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of treatment of vitamin D deficiency over a one year time frame: normalization of vitamin D levels above 30ng/mL | 12months | Looking for normalization of vitamin D levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of efficacy after starting vitamin D replacement as monitored at one week and then three month intervals for one year | 1 week, 3 months, 6 months, 9 months, 12 months | Evaluation of how long participants maintain normal vitamin D levels with treatment |
| 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 | 1 week, 3 months, 6 months, 9 months, 12 months | Evaluation of missed doses |
Countries
United States
Outcome results
None listed