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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This study has been withdrawn prior to enrollment.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:
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT01633658
First received: July 2, 2012
Last updated: May 27, 2013
Last verified: May 2013
  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:


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.


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

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
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: 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

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: May 27, 2013
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
Hydroxycholecalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 19, 2014