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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 26, 2014