NCT01765010

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 10, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

January 10, 2013

Status Verified

January 1, 2013

Enrollment Period

2 months

First QC Date

January 8, 2013

Last Update Submit

January 8, 2013

Conditions

Osteoporosis

Keywords

Vitamin DSerum sclerostinSerum dickkopf1

Outcome Measures

Primary Outcomes (2)

  • Change of serum sclerostin level

    8 weeks later

  • Change of serum Dickkopf1 level

    8 weeks later

Secondary Outcomes (4)

  • 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

Study Arms (4)

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

CalcitriolDRUG
Also known as: Calcio
Calcitriol
AlfacalcidolDRUG
Also known as: Onealfa
alfacalcidol
CholecalciferolDRUG
Also known as: DicamaxD
Cholecalciferol 1000IU
PlaceboDRUG
Placebo control

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male volunteer older than 20 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Medical School

Seoul, 110-744, South Korea

RECRUITING

MeSH Terms

Conditions

Osteoporosis

Interventions

CalcitriolCalciumalfacalcidolCholecalciferol

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DihydroxycholecalciferolsHydroxycholecalciferolsCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipidsMetals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological Factors

Study Officials

  • Chan Soo Shin, MD, PhD

    Seoul National University Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chan Soo Shin, MD, PhD

CONTACT

+82-2-2072-3734csshin@snu.ac.kr

Jung Hee Kim, MD

CONTACT

+82-2-2072-4839jhkxingfu@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2013

First Posted

January 10, 2013

Study Start

January 1, 2013

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

January 10, 2013

Record last verified: 2013-01

Locations

KR(1)