Treatment of Vitamin D Deficiency With Large Bolus Cholecalciferol

Phase 1

Terminated

• Conditions: Vitamin D Deficiency
• Interventions: Drug: Cholecalciferol

• Registration Number: NCT04120064
• Lead Sponsor: Parkview Medical Center

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.

Study Timeline

• Study Start: 2019-01-25
• Study First Submitted: 2019-09-06
• Study First Submitted QC: 2019-10-04
• Study First Posted: 2019-10-09
• Primary Completion: 2020-12-31
• Status Verified: 2021-01
• Study Completion: 2021-01-15
• Last Update Submitted: 2021-01-27
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Large bolus	Cholecalciferol	-
Standard	Cholecalciferol	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Parkview Medical Center; 🇺🇸 Pueblo, Colorado, United States