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Relative Efficacy of Vitamins D2 and D3 in Adult Humans

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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

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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: vitamin D2 Dietary Supplement: vitamin D3 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vitamin D Status: Relative Efficacy of Vitamins D2 and D3
Study Start Date : January 2010
Actual Primary Completion Date : August 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: vitamin D2 Dietary Supplement: vitamin D2
Study Supplement
Active Comparator: vitamin D3 Dietary Supplement: vitamin D3
Study Supplement



Primary Outcome Measures :
  1. AUC for increment in serum 25(OH)D [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. change in vitamin D content of subcutaneous fat [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01139840


Locations
United States, Nebraska
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Health Future Foundation
BTR Group
Investigators
Principal Investigator: Robert P Heaney, MD Creighton University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT01139840     History of Changes
Other Study ID Numbers: 09-15612
First Posted: June 9, 2010    Key Record Dates
Last Update Posted: October 31, 2011
Last Verified: October 2011

Keywords provided by Creighton University:
vitamin D2
vitamin D3
ergocalciferol
cholecalciferol
vitamin D status
To determine relative potency of vitamins D2 and D3 under conditions of continuous administration
To determine change in vitamin D content of subcutaneous fat after 12 weeks' administration

Additional relevant MeSH terms:
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents