Treatment of Vitamin D Deficiency With Large Bolus Cholecalciferol

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04120064
• Other study ID #: PIRB64
• Status: Terminated
• Phase: Phase 1
• Start date: January 25, 2019
• Est. completion date: January 15, 2021

Study information

• Verified date: January 2021
• Source: Parkview Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: January 15, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Drug:
• Cholecalciferol
Large, one time dose of 300,000 IU oral cholecalciferol or daily 5,000 IU oral cholecalciferol

Locations

Country	Name	City	State
United States	Parkview Medical Center	Pueblo	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Parkview Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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