None listed
Conditions
Brief summary
The study will determine the range of oral doses of vitamin D that are necessary to raise blood levels of vitamin D to an extent that may have positive effects in patients with rheumatoid arthritis. This study will not examine rheumatoid arthritis outcomes, but the results will be used to plan a later study with rheumatoid patients to examine the effects of vitamin D.
Interventions
Oral vitamin D3 at starting dose of 20,000U per week followed by dose adjustment 6-weekly to achieve a target serum 25-OH vitamin D3 concentration of 140-180 nmol/L. Each participant will be on trial for 12 months, regardless of whether or not they have achieved the target serum 25-OH vitamin D3 levels.
Sponsors
Michael James
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients attending rheumatology outpatient clinics, serum 25-hydroxy vitamin D3 < 100 nmol/L
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
Outcome results
None listed