Dose-Finding Study of the Relationship between Oral Vitamin D3 and Serum 25-Hydroxy Vitamin D3 Concentration. Protocol: ODS25

Not Applicable

Withdrawn

• Conditions: il; Nil; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12609000203257
• Lead Sponsor: Michael James

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patients attending rheumatology outpatient clinics, serum 25-hydroxy vitamin D3 < 100 nmol/

Exclusion Criteria

Pregnancy and lactation, women of childbearing age not using contraception, history of hypercalcemia or parathyroid disease, chronic renal failure with evidence of renal stones (calculated creatinine clearance must be > 50 ml/min by the Cockcroft-Gault equation), sarcoidosis with hypercalcemia, unsuppressed Pagets disease, metastatic bone disease, calcium pyrophosphate deposition disease (pseudogout), heterogenous calcification

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is descriptive. It will document the range of oral vit D3 dose(s) required to achieve a serum concentration of 140-180 nmol/L 25-OH vitamin D3 at two successive 6-weekly measures. The serum 25-OH vitamin D3 will be determined by radioimmunoassay.[The achievement of target concentrations of serum 25-OH vitamin D3 at two successive 6-weekly measures is expected to occur at different times in different participants. However, all participants will continue on-study for 12 months after the initial oral vitamin D3 administration.]

Secondary Outcome Measures

Name	Time	Method
il[N/A]