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Pilot Pharmacokinetic Study of Daily Versus Monthly High-Dose Cholecalciferol Supplementation

18 Years
40 Years
Not Enrolling
Healthy Volunteers

Thank you

Trial Information

Pilot Pharmacokinetic Study of Daily Versus Monthly High-Dose Cholecalciferol Supplementation

Inclusion Criteria:

- Age 18 to 40 years

- non-pregnant

- non-lactating

- female

- willing to participate in study with adequate compliance and follow-up

Exclusion Criteria:

- Any clinically significant underlying chronic disease states (i.e. diabetes, asthma,
seizure disorders, hypo/hyperthyroidism, hypercalcemia, hypophosphatemia, other
endocrine disorders, absorption disorders)

- allergy to study medication or its components

- significant travel south of the 35° North latitude in the 28-day study period

- chronic use of steroids, anti-convulsants, or barbiturates

- participation in indoor tanning practices during the 28-day study period

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Vitamin D pharmacokinetics

Outcome Description:

Characterize the differences in pharmacokinetics of oral Vitamin D3 between two dosing regimens within women of child-bearing age by evaluating any changes in the number of days of detectable total serum Vitamin D and area under the curve (AUC) above baseline.

Outcome Time Frame:

28 days

Safety Issue:


Principal Investigator

Bernard R Lee, PharmD, BCPS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic


United States: Institutional Review Board

Study ID:




Start Date:

February 2010

Completion Date:

June 2010

Related Keywords:

  • Healthy Volunteers
  • healthy volunteers
  • healthy subjects
  • vitamin D
  • cholecalciferol
  • vitamin D3
  • total vitamin D



Mayo Clinic Rochester, Minnesota  55905