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Relative Efficacy of Vitamins D2 and D3 in Adult Humans

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: NCT01139840
Recruitment Status : Completed
First Posted : June 9, 2010
Last Update Posted : October 31, 2011
Sponsor:
Collaborators:
Health Future Foundation
BTR Group
Information provided by (Responsible Party):
Creighton University

Tracking Information
First Submitted Date  ICMJE June 7, 2010
First Posted Date  ICMJE June 9, 2010
Last Update Posted Date October 31, 2011
Study Start Date  ICMJE January 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2010)
AUC for increment in serum 25(OH)D [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2010)
change in vitamin D content of subcutaneous fat [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Relative Efficacy of Vitamins D2 and D3 in Adult Humans
Official Title  ICMJE Vitamin D Status: Relative Efficacy of Vitamins D2 and D3
Brief Summary Vitamin D2 in chronic dosing will produce less of an elevation of serum 25(OH)D than will the same dose of vitamin D3.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Healthy
Intervention  ICMJE
  • Dietary Supplement: vitamin D2
    Study Supplement
  • Dietary Supplement: vitamin D3
    Study Supplement
Study Arms  ICMJE
  • Active Comparator: vitamin D2
    Intervention: Dietary Supplement: vitamin D2
  • Active Comparator: vitamin D3
    Intervention: Dietary Supplement: vitamin D3
Publications * Heaney RP, Recker RR, Grote J, Horst RL, Armas LA. Vitamin D(3) is more potent than vitamin D(2) in humans. J Clin Endocrinol Metab. 2011 Mar;96(3):E447-52. doi: 10.1210/jc.2010-2230. Epub 2010 Dec 22.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: June 8, 2010)
32
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • willingness to withhold supplement use for duration of study
  • willingness to avoid sun exposure for duration of study

Exclusion Criteria:

  • vitamin D supplement use
  • conditions that affect vitamin D metabolism by the body
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older 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 NCT01139840
Other Study ID Numbers  ICMJE 09-15612
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
  • Health Future Foundation
  • BTR Group
Investigators  ICMJE
Principal Investigator: Robert P Heaney, MD Creighton University
PRS Account Creighton University
Verification Date October 2011

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