Pilot Pharmacokinetic Study of Daily Versus Monthly High-Dose Cholecalciferol Supplementation
N/A
18 Years
40 Years
18 Years
40 Years
Not Enrolling
Female
Healthy Volunteers
Female
Healthy Volunteers
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:
Interventional
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:
No
Principal Investigator
Bernard R Lee, PharmD, BCPS
Investigator Role:
Principal Investigator
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Institutional Review Board
Study ID:
09-007602
NCT ID:
NCT01079923
Start Date:
February 2010
Completion Date:
June 2010
Related Keywords:
- Healthy Volunteers
- healthy volunteers
- healthy subjects
- vitamin D
- cholecalciferol
- vitamin D3
- total vitamin D
Name | Location |
|---|---|
| Mayo Clinic | Rochester, Minnesota 55905 |
