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

Vitamin D Deficiency Clinical Trial

Official title:

The Variability of 25-hydroxyvitamin D Response From Crystalline 25-hydroxyvitamin D3 Compared to Native Vitamin D3: A Short Term Pharmacokinetic Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01633658
• Other study ID #: Creighton 13
• Status: Withdrawn
• Phase: N/A
• First received: July 2, 2012
• Last updated: May 27, 2013
• Start date: November 2012
• Est. completion date: November 2013

Study information

• Verified date: May 2013
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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"

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Dietary Supplement:
• cholecalciferol
a single dose of 2500 micrograms of cholecalciferol
• 25(OH)D
a single dose of 625 micrograms of 25(OH)D

Locations

Country	Name	City	State
United States	Creighton University	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Creighton University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum 25(OH)D response	25(OH)D will be measured at frequent time intervals over 28 days.	28 days	No