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

This study is not yet open for participant recruitment.
Verified July 2012 by Creighton University
Sponsor:
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT01633658
First received: July 2, 2012
Last updated: July 3, 2012
Last verified: July 2012
History of Changes
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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:

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

Further study details as provided by Creighton University:

Primary Outcome Measures:
  • Serum 25(OH)D response [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    25(OH)D will be measured at frequent time intervals over 28 days.


Estimated Enrollment: 20
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

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01633658

Contacts
Contact: Susan Dowell, RN PhD 402-280-4647 marydowell@creighton.edu
Contact: Erin Schechinger 402-280-4647 erinschechinger@creighton.edu

Locations
United States, Nebraska
Creighton University Not yet recruiting
Omaha, Nebraska, United States, 68131
Contact: Susan Dowell, RN, PhD     402-280-4647     marydowell@creighton.edu    
Contact: Laura AG Armas, MD,MS     402-280-4470     larmas@creighton.edu    
Sponsors and Collaborators
Creighton University
Investigators
Principal Investigator: Laura Armas, MD,MS Creighton University
  More Information

No publications provided

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT01633658     History of Changes
Other Study ID Numbers: Creighton 13
Study First Received: July 2, 2012
Last Updated: July 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Creighton University:
vitamin D

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

ClinicalTrials.gov processed this record on May 19, 2013