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

This study has been withdrawn prior to enrollment.
(Protocol has changed)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01633658
First Posted: July 4, 2012
Last Update Posted: May 29, 2013
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.
Information provided by (Responsible Party):
Creighton University
  Purpose
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.

Condition Intervention
Vitamin D Deficiency Dietary Supplement: cholecalciferol Dietary Supplement: 25(OH)D

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: The Variability of 25-hydroxyvitamin D Response From Crystalline 25-hydroxyvitamin D3 Compared to Native Vitamin D3: A Short Term Pharmacokinetic Study

Resource links provided by NLM:


Further study details as provided by Creighton University:

Primary Outcome Measures:
  • Serum 25(OH)D response [ Time Frame: 28 days ]
    25(OH)D will be measured at frequent time intervals over 28 days.


Enrollment: 0
Study Start Date: November 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin D Cholecalciferol
A single dose of 2500 micrograms cholecalciferol
Dietary Supplement: cholecalciferol
a single dose of 2500 micrograms of cholecalciferol
Experimental: 25(OH)D
A single dose of 625 micrograms 25(OH)D
Dietary Supplement: 25(OH)D
a single dose of 625 micrograms of 25(OH)D

Detailed Description:
Single blind, active control, pharmacokinetic study of 625 μg 25(OH)D given orally or 2500 μg native vitamin D given orally.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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"
  Contacts and Locations
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): NCT01633658


Locations
United States, Nebraska
Creighton University
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Investigators
Principal Investigator: Laura Armas, MD,MS Creighton University
  More Information

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT01633658     History of Changes
Other Study ID Numbers: Creighton 13
First Submitted: July 2, 2012
First Posted: July 4, 2012
Last Update Posted: May 29, 2013
Last Verified: May 2013

Keywords provided by Creighton University:
vitamin D

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Hydroxycholecalciferols
Calcifediol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents