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

NCT ID: NCT01765010

Last Updated: 2013-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-03-31

Brief Summary

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

Detailed Description

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Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Placebo control

Placebo control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Cholecalciferol 1000IU

Cholecalciferol 1000IU qd for 8 weeks

Group Type ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type DRUG

alfacalcidol

alfacalcidol 0.5ug qd for 8 weeks

Group Type EXPERIMENTAL

Alfacalcidol

Intervention Type DRUG

Calcitriol

Calcitriol 0.25ug qd for 8 weeks

Group Type EXPERIMENTAL

Calcitriol

Intervention Type DRUG

Interventions

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Calcitriol

Intervention Type DRUG

Alfacalcidol

Intervention Type DRUG

Cholecalciferol

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Calcio Onealfa DicamaxD

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chan Soo Shin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Medical School

Locations

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Seoul National University Medical School

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Chan Soo Shin, MD, PhD

Role: CONTACT

+82-2-2072-3734

Jung Hee Kim, MD

Role: CONTACT

+82-2-2072-4839

Facility Contacts

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Chan Soo Shin, MD, PhD

Role: primary

82220723734

Jung Hee Kim, MD

Role: backup

8220724839

Other Identifiers

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SNUH-ENDO-2013

Identifier Type: -

Identifier Source: org_study_id

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