Treatment of Vitamin D Deficiency With Large Bolus Cholecalciferol

Parkview Medical Center

Status and phase: Terminated; Phase 1

Conditions: Vitamin D Deficiency

Treatments: Drug: Cholecalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT04120064

PIRB64

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Large bolus

Experimental group

Treatment:

Drug: Cholecalciferol

Standard

Active Comparator group

Treatment:

Drug: Cholecalciferol