Relative Efficacy of Vitamins D2 and D3 in Adult Humans

This study has been completed.
Sponsor:
Collaborators:
Health Future Foundation
BTR Group
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT01139840
First received: June 7, 2010
Last updated: October 27, 2011
Last verified: October 2011
  Purpose

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 Intervention
Healthy
Dietary Supplement: vitamin D2
Dietary Supplement: vitamin D3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vitamin D Status: Relative Efficacy of Vitamins D2 and D3

Resource links provided by NLM:


Further study details as provided by Creighton University:

Primary Outcome Measures:
  • AUC for increment in serum 25(OH)D [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in vitamin D content of subcutaneous fat [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: January 2010
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: vitamin D2 Dietary Supplement: vitamin D2
Study Supplement
Active Comparator: vitamin D3 Dietary Supplement: vitamin D3
Study Supplement

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Creighton University

Additional 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
Study First Received: June 7, 2010
Last Updated: October 27, 2011
Health Authority: United States: Institutional Review Board

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:
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 16, 2014