Treatment of Vitamin D Deficiency With Large Bolus Cholecalciferol

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

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

Study Overview

• Status: Terminated
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Drug: Cholecalciferol

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Pueblo, Colorado, United States, 81003
      • Parkview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard	Drug: Cholecalciferol; Large, one time dose of 300,000 IU oral cholecalciferol or daily 5,000 IU oral cholecalciferol
Experimental: Large bolus	Drug: Cholecalciferol; Large, one time dose of 300,000 IU oral cholecalciferol or daily 5,000 IU oral cholecalciferol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Parkview Medical Center
• Investigators: Study Chair: Stephanie Murphy, DO, Parkview Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): January 15, 2021

Study Registration Dates

• First Submitted: September 6, 2019
• First Submitted That Met QC Criteria: October 4, 2019
• First Posted (Actual): October 9, 2019

Study Record Updates

• Last Update Posted (Actual): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 27, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: PIRB64

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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