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

Phase 4

• Conditions: Osteoporosis
• Interventions: Drug: Placebo; Drug: Cholecalciferol; Drug: Alfacalcidol; Drug: Calcitriol

• Registration Number: NCT01765010
• Lead Sponsor: Seoul National University Hospital

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 available

Study Timeline

• Status Verified: 2013-01
• Study Start: 2013-01
• Study First Submitted: 2013-01-08
• Study First Submitted QC: 2013-01-08
• Last Update Submitted: 2013-01-08
• Study First Posted: 2013-01-10
• Last Update Posted: 2013-01-10
• Primary Completion: 2013-03
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Placebo control	Placebo	Placebo control
Cholecalciferol 1000IU	Cholecalciferol	Cholecalciferol 1000IU qd for 8 weeks
alfacalcidol	Alfacalcidol	alfacalcidol 0.5ug qd for 8 weeks
Calcitriol	Calcitriol	Calcitriol 0.25ug qd for 8 weeks

Primary Outcome Measures

Name	Time	Method
Change of serum sclerostin level	8 weeks later
Change of serum Dickkopf1 level	8 weeks later

Secondary Outcome Measures

Name	Time	Method
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	8 weeks later
Change of serum parathyroid hormone level	8 weeks later

Trial Locations

Locations (1)

Seoul National University Medical School; 🇰🇷 Seoul, Korea, Republic of