NCT04120064

Treatment of Vitamin D Deficiency With Large Bolus Cholecalciferol

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Parkview Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vitamin D Deficiency

Interventions

Type	Name	Description
DRUG	Cholecalciferol	Large, one time dose of 300,000 IU oral cholecalciferol or daily 5,000 IU oral cholecalciferol

Timeline

• Start date: 2019-01-25
• Primary completion: 2020-12-31
• Completion: 2021-01-15
• First posted: 2019-10-09
• Last updated: 2021-02-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study