The Effect of Inactive and Active Vitamin D on Serum Scle... | NCT01765010

Studies
The Effect of Inactive and Active Vitamin D on Serum Sclerostin/dickkopf1 Levels

NCT01765010

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Jan 10, 2013Estimated

Enrollment

88Estimated

Phase

Phase 4

Conditions

Osteoporosis

Interventions

Calcitriol
Alfacalcidol
Cholecalciferol
Placebo

Countries

South Korea

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

Jan 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Mar 2013Estimated

Completion Date

Mar 2013Estimated

First Submitted Date

Jan 8, 2013

First Submission Date that Met QC Criteria

Jan 8, 2013

First Posted Date

Jan 10, 2013Estimated

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

Jan 8, 2013

Last Update Posted Date

Jan 10, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 purpose of this study is to compare the effect of inactive and active vitamin D on serum sclerostin and dickkopf1 levels.

Detailed Description

Not provided

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

88Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo control	Placebo Comparator	Placebo control	Drug: Placebo
Cholecalciferol 1000IU	Active Comparator	Cholecalciferol 1000IU qd for 8 weeks	Drug: Cholecalciferol
alfacalcidol	Experimental	alfacalcidol 0.5ug qd for 8 weeks	Drug: Alfacalcidol
Calcitriol	Experimental	Calcitriol 0.25ug qd for 8 weeks	Drug: Calcitriol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Calcitriol	Drug		Calcitriol	Calcio
Alfacalcidol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of serum sclerostin level		8 weeks later
Change of serum Dickkopf1 level		8 weeks later

Secondary Outcomes

Measure	Description	Time Frame
Change of serum c-telopeptide level		8 weeks later
Change of serum bone-specific alkaline phosphatase level		8 weeks later
Change of serum calcium level

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male volunteer older than 20 years

Exclusion Criteria:

Subjects with bone and mineral metabolism disorders
Subjects with kidney or liver diseases
Subjects with uncorrectable hypercalcemia or hypocalcemia
Subjects with chronic gastrointestinal disorders or malabsorption
Subjects taking medication related to bone loss

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chan Soo Shin, MD, PhD	Contact	+82-2-2072-3734		csshin@snu.ac.kr
Jung Hee Kim, MD	Contact	+82-2-2072-4839		jhkxingfu@gmail.com

Overall Officials

Name	Affiliation	Role
Chan Soo Shin, MD, PhD	Seoul National University Medical School	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Medical School	Recruiting	Seoul		110-744	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D010024	Osteoporosis

Ancestor Terms

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002117	Calcitriol
D002118	Calcium
C008088	alfacalcidol
D002762	Cholecalciferol

Ancestor Terms

ID	Term
D004100	Dihydroxycholecalciferols
D006887	Hydroxycholecalciferols
D002782	Cholestenes
D002776	Cholestanes

Browse Leaves

Not provided

Browse Branches

Not provided