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

January 8, 2013 updated by: Seoul National University Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

88

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Recruiting
        • Seoul National University Medical School
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chan Soo Shin, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo control
Drug: Placebo
Active Comparator: Cholecalciferol 1000IU
Cholecalciferol 1000IU qd for 8 weeks
Drug: Cholecalciferol
Other Names:
  • DicamaxD
Experimental: alfacalcidol
alfacalcidol 0.5ug qd for 8 weeks
Drug: Alfacalcidol
Other Names:
  • Onealfa
Experimental: Calcitriol
Calcitriol 0.25ug qd for 8 weeks
Drug: Calcitriol
Other Names:
  • Calcio

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of serum c-telopeptide level
Time Frame: 8 weeks later
8 weeks later
Change of serum bone-specific alkaline phosphatase level
Time Frame: 8 weeks later
8 weeks later
Change of serum calcium level
Time Frame: 8 weeks later
8 weeks later
Change of serum parathyroid hormone level
Time Frame: 8 weeks later
8 weeks later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Chan Soo Shin, MD, PhD, Seoul National University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

March 1, 2013

Study Completion (Anticipated)

March 1, 2013

Study Registration Dates

First Submitted

January 8, 2013

First Submitted That Met QC Criteria

January 8, 2013

First Posted (Estimate)

January 10, 2013

Study Record Updates

Last Update Posted (Estimate)

January 10, 2013

Last Update Submitted That Met QC Criteria

January 8, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUH-ENDO-2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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