Back to resultsTreatment of Vitamin D Deficiency With Large Bolus Cholecalciferol
Primary Purpose
Vitamin D Deficiency
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cholecalciferol
Sponsored by
About this trial
This is an interventional treatment trial for Vitamin D Deficiency
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
Sites / Locations
- Parkview Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Large bolus
Standard
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT04120064
First Posted
September 6, 2019
Last Updated
January 27, 2021
Sponsor
Parkview Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04120064
Brief Title
Treatment of Vitamin D Deficiency With Large Bolus Cholecalciferol
Official Title
Treatment of Vitamin D Deficiency With Large Bolus Cholecalciferol in the Outpatient Setting
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
Covid19, not able to finish recruitment
Study Start Date
January 25, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
January 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Parkview Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Large bolus
Arm Type
Experimental
Arm Title
Standard
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Intervention Description
Large, one time dose of 300,000 IU oral cholecalciferol or daily 5,000 IU oral cholecalciferol
Primary Outcome Measure Information:
Title
Efficacy of treatment of vitamin D deficiency over a one year time frame: normalization of vitamin D levels above 30ng/mL
Description
Looking for normalization of vitamin D levels
Time Frame
12months
Secondary Outcome Measure Information:
Title
Duration of efficacy after starting vitamin D replacement as monitored at one week and then three month intervals for one year
Description
Evaluation of how long participants maintain normal vitamin D levels with treatment
Time Frame
1 week, 3 months, 6 months, 9 months, 12 months
Title
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
Description
Evaluation of missed doses
Time Frame
1 week, 3 months, 6 months, 9 months, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Murphy, DO
Organizational Affiliation
Parkview Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Parkview Medical Center
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81003
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of Vitamin D Deficiency With Large Bolus Cholecalciferol
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