Treatment of Vitamin D Deficiency With Large Bolus Cholecalciferol

NCT ID: NCT04120064

Last Updated: 2021-02-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-25
• Study Completion Date: 2021-01-15

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.

Conditions

Vitamin D Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Large bolus

Group Type: EXPERIMENTAL

Cholecalciferol

Intervention Type: DRUG

Large, one time dose of 300,000 IU oral cholecalciferol or daily 5,000 IU oral cholecalciferol

Standard

Group Type: ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type: DRUG

Large, one time dose of 300,000 IU oral cholecalciferol or daily 5,000 IU oral cholecalciferol

Interventions

Cholecalciferol

Large, one time dose of 300,000 IU oral cholecalciferol or daily 5,000 IU oral cholecalciferol

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parkview Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Doug Duffee

Administrator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephanie Murphy, DO

Role: STUDY_CHAIR

Parkview Medical Center

Locations

Parkview Medical Center

Pueblo, Colorado, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

PIRB64

Identifier Type: -

Identifier Source: org_study_id