Relative Efficacy of Vitamins D2 and D3 in Adult Humans | NCT01139840

Studies
Relative Efficacy of Vitamins D2 and D3 in Adult Humans

NCT01139840

Sponsor

Creighton University

Status

Completed

Last Update Posted

Oct 31, 2011Estimated

Enrollment

32Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

vitamin D2
vitamin D3

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

Oct 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Aug 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Jun 7, 2010

First Submission Date that Met QC Criteria

Jun 8, 2010

First Posted Date

Jun 9, 2010Estimated

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

Oct 27, 2011

Last Update Posted Date

Oct 31, 2011Estimated

Name	Class
Health Future Foundation	UNKNOWN
BTR Group	INDUSTRY

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

Vitamin D2 in chronic dosing will produce less of an elevation of serum 25(OH)D than will the same dose of vitamin D3.

Detailed Description

Not provided

Conditions Module

Conditions

Healthy

Keywords

vitamin D2
vitamin D3
ergocalciferol
cholecalciferol
vitamin D status
To determine relative potency of vitamins D2 and D3 under conditions of continuous administration
To determine change in vitamin D content of subcutaneous fat after 12 weeks' administration

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

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
vitamin D2	Active Comparator		Dietary Supplement: vitamin D2
vitamin D3	Active Comparator		Dietary Supplement: vitamin D3

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vitamin D2	Dietary Supplement	Study Supplement	vitamin D2
vitamin D3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUC for increment in serum 25(OH)D		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
change in vitamin D content of subcutaneous fat		12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

willingness to withhold supplement use for duration of study
willingness to avoid sun exposure for duration of study

Exclusion Criteria:

vitamin D supplement use
conditions that affect vitamin D metabolism by the body

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert P Heaney, MD	Creighton University	Principal Investigator

Locations

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21177785	Derived	Heaney RP, Recker RR, Grote J, Horst RL, Armas LA. Vitamin D(3) is more potent than vitamin D(2) in humans. J Clin Endocrinol Metab. 2011 Mar;96(3):E447-52. doi: 10.1210/jc.2010-2230. Epub 2010 Dec 22.

ID	Term
D004872	Ergocalciferols
D002762	Cholecalciferol

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