Treatment of Vitamin D Deficiency With Large Bolus Cholecalciferol

NCT04120064 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: PIRB64
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Study Arms (2)

Large bolus

EXPERIMENTAL

Drug: Cholecalciferol

Standard

ACTIVE COMPARATOR

Drug: Cholecalciferol

Interventions

Cholecalciferol DRUG

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

Large bolus; Standard

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Parkview Medical Center: lead

Study Sites (1)

Parkview Medical Center

Pueblo, Colorado, 81003, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Stephanie Murphy, DO

  Parkview Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Administrator

Study Record Dates

• First Submitted: September 6, 2019
• First Posted: October 9, 2019
• Study Start: January 25, 2019
• Primary Completion: December 31, 2020
• Study Completion: January 15, 2021
• Last Updated: February 1, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)