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The Variability of 25-hydroxyvitamin D Response From Crystalline 25-hydroxyvitamin D3

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01633658
Recruitment Status : Withdrawn (Protocol has changed)
First Posted : July 4, 2012
Last Update Posted : May 29, 2013
Sponsor:
Information provided by (Responsible Party):
Creighton University

Tracking Information
First Submitted Date  ICMJE July 2, 2012
First Posted Date  ICMJE July 4, 2012
Last Update Posted Date May 29, 2013
Study Start Date  ICMJE November 2012
Estimated Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2012)
Serum 25(OH)D response [ Time Frame: 28 days ]
25(OH)D will be measured at frequent time intervals over 28 days.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Variability of 25-hydroxyvitamin D Response From Crystalline 25-hydroxyvitamin D3
Official Title  ICMJE The Variability of 25-hydroxyvitamin D Response From Crystalline 25-hydroxyvitamin D3 Compared to Native Vitamin D3: A Short Term Pharmacokinetic Study
Brief Summary The investigators hypothesize that native vitamin D will have more variability in 25(OH)D dose response when compared to a given equipotent dose of 25-hydroxyvitamin D3. This will be a single blind, active control, pharmacokinetic study of 625 μg 25(OH)D given orally or 2500 μg native vitamin D given orally.
Detailed Description Single blind, active control, pharmacokinetic study of 625 μg 25(OH)D given orally or 2500 μg native vitamin D given orally.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Condition  ICMJE Vitamin D Deficiency
Intervention  ICMJE
  • Dietary Supplement: cholecalciferol
    a single dose of 2500 micrograms of cholecalciferol
  • Dietary Supplement: 25(OH)D
    a single dose of 625 micrograms of 25(OH)D
Study Arms  ICMJE
  • Active Comparator: Vitamin D Cholecalciferol
    A single dose of 2500 micrograms cholecalciferol
    Intervention: Dietary Supplement: cholecalciferol
  • Experimental: 25(OH)D
    A single dose of 625 micrograms 25(OH)D
    Intervention: Dietary Supplement: 25(OH)D
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 27, 2013)
0
Original Estimated Enrollment  ICMJE
 (submitted: July 3, 2012)
20
Estimated Study Completion Date  ICMJE November 2013
Estimated Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ten men and women in each group,
  • aged 20-60.

Exclusion Criteria:

  • History of hypercalcemia,
  • vitamin D supplement use > 800 IU daily,
  • BMI > 30,
  • gastrointestinal malabsorption (from celiac sprue, colitis, surgery, etc.), kidney disease or liver disease,
  • use of steroids in any form,
  • anticonvulsants,
  • antibiotics,
  • acute illness, or
  • vacation planned to "sunny climate"
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01633658
Other Study ID Numbers  ICMJE Creighton 13
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Creighton University
Study Sponsor  ICMJE Creighton University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Laura Armas, MD,MS Creighton University
PRS Account Creighton University
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP