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

This study is currently recruiting participants.
Verified January 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01765010
First received: January 8, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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


Condition Intervention Phase
Osteoporosis
 Drug: Calcitriol
Drug: Alfacalcidol
Drug: Cholecalciferol
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparisons of the Effect of Inactive and Active Vitamin D on Serum Sclerostin/dickkopf1 Levels

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Change of serum sclerostin level [ Time Frame: 8 weeks later ] [ Designated as safety issue: No ]
  • Change of serum Dickkopf1 level [ Time Frame: 8 weeks later ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change of serum c-telopeptide level [ Time Frame: 8 weeks later ] [ Designated as safety issue: No ]
  • Change of serum bone-specific alkaline phosphatase level [ Time Frame: 8 weeks later ] [ Designated as safety issue: No ]
  • Change of serum calcium level [ Time Frame: 8 weeks later ] [ Designated as safety issue: Yes ]
  • Change of serum parathyroid hormone level [ Time Frame: 8 weeks later ] [ Designated as safety issue: No ]

Estimated Enrollment: 88
Study Start Date: January 2013
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo control
Placebo control
 Drug: Placebo
Other Name: placebo
Active Comparator: Cholecalciferol 1000IU
Cholecalciferol 1000IU qd for 8 weeks
 Drug: Cholecalciferol
Other Name: DicamaxD
Experimental: alfacalcidol
alfacalcidol 0.5ug qd for 8 weeks
 Drug: Alfacalcidol
Other Name: Onealfa
Experimental: Calcitriol
Calcitriol 0.25ug qd for 8 weeks
 Drug: Calcitriol
Other Name: Calcio

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01765010

Contacts
Contact: Chan Soo Shin, MD, PhD +82-2-2072-3734 csshin@snu.ac.kr
Contact: Jung Hee Kim, MD +82-2-2072-4839 jhkxingfu@gmail.com

Locations
Korea, Republic of
Seoul National University Medical School Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Chan Soo Shin, MD, PhD     82220723734     csshin@snu.ac.kr    
Contact: Jung Hee Kim, MD     8220724839     jhkxingfu@gmail.com    
Principal Investigator: Chan Soo Shin, MD, PhD            
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Chan Soo Shin, MD, PhD Seoul National University Medical School
  More Information

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01765010     History of Changes
Other Study ID Numbers: SNUH-ENDO-2013
Study First Received: January 8, 2013
Last Updated: January 8, 2013
Health Authority: Korea: Food and Drug Administration
Korea: Ministry for Health, Welfare and Family Affairs

Keywords provided by Seoul National University Hospital:
Vitamin D
Serum sclerostin
Serum dickkopf1

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Calcitriol
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Hydroxycholecalciferols
1-hydroxycholecalciferol
 Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013