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

Seoul National University

Status and phase: Unknown; Phase 4

Conditions: Osteoporosis

Treatments: Drug: Placebo; Drug: Calcitriol; Drug: Cholecalciferol; Drug: Alfacalcidol

Study type: Interventional

Funder types: Other

Identifiers

NCT01765010

SNUH-ENDO-2013

Details and patient eligibility

About

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

Enrollment: 88 estimated patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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88 participants in 4 patient groups, including a placebo group

Placebo control

Placebo Comparator group

Description:

Placebo control

Treatment:

Drug: Placebo

Cholecalciferol 1000IU

Active Comparator group

Description:

Cholecalciferol 1000IU qd for 8 weeks

Treatment:

Drug: Cholecalciferol

alfacalcidol

Experimental group

Description:

alfacalcidol 0.5ug qd for 8 weeks

Treatment:

Drug: Alfacalcidol

Calcitriol

Experimental group

Description:

Calcitriol 0.25ug qd for 8 weeks

Treatment:

Drug: Calcitriol