The Variability of 25-hydroxyvitamin D Response From Crys... | NCT01633658

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

NCT01633658

Sponsor

Creighton University

Status

Withdrawn

Last Update Posted

May 29, 2013Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Vitamin D Deficiency

Interventions

cholecalciferol
25(OH)D

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Protocol has changed

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Nov 2013Estimated

Completion Date

Nov 2013Estimated

First Submitted Date

Jul 2, 2012

First Submission Date that Met QC Criteria

Jul 3, 2012

First Posted Date

Jul 4, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2013

Last Update Posted Date

May 29, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vitamin D Cholecalciferol	Active Comparator	A single dose of 2500 micrograms cholecalciferol	Dietary Supplement: cholecalciferol
25(OH)D	Experimental	A single dose of 625 micrograms 25(OH)D	Dietary Supplement: 25(OH)D

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cholecalciferol	Dietary Supplement	a single dose of 2500 micrograms of cholecalciferol	Vitamin D Cholecalciferol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum 25(OH)D response	25(OH)D will be measured at frequent time intervals over 28 days.	28 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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"

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Laura Armas, MD,MS	Creighton University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Creighton University		Omaha	Nebraska	68131	United States

Condition Browse Module

MeSH Terms

ID	Term
D014808	Vitamin D Deficiency

Ancestor Terms

ID	Term
D001361	Avitaminosis
D003677	Deficiency Diseases
D044342	Malnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002762	Cholecalciferol

Ancestor Terms

ID	Term
D002782	Cholestenes
D002776	Cholestanes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided