Hypovitaminosis D
Conditions
Keywords
vitamin D supplementation, cholecalciferol, PTH, bone turnover markers, elderly women
Brief summary
The purpose of this study is to determine if infrequent administration of oral vitamin D megadoses is effective treatment to maintain serum 25-hydroxyvitamin D(3) above target levels of 50-75 nmol/L. The investigators hypothesize that 100 000 IU or at least 200 000 IU vitamin D3 in every three months would be effective and safe treatment to achieve the target levels.
Interventions
DIETARY_SUPPLEMENTvitamin D3 (cholecalciferol)
vitamin D3 (cholecalciferol) oil 20 000 IU/ml, oral dose of 200 000 IU or 100 000 IU (10ml or 5ml) every three months for one year.
OTHERolive oil
10 ml (placebo group) or 5 ml (100 000 IU vitamin D3 group) oil per os every three months for one year
DIETARY_SUPPLEMENTcalcium carbonate
1000 mg calcium per os every day for one year
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
70 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* female * 70-80 yrs old
Exclusion criteria
* disease or medication affecting calcium homeostasis * renal failure (Pt-GFRe-CG \< 35 ml/min)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum 25(OH)D3 concentration in relation to the target levels of 50-75 nmol/L | 12 months (including 9 time points) |
Secondary
| Measure | Time frame |
|---|---|
| Hypercalciuria (dU-Ca >10 mmol/24h) | 12 months (including 9 timepoints) |
| Hypercalcemia (S-Ca-ion >1,3 mmol/l) | 12 months (including 9 timepoints) |
| Decline of creatine clearance (Pt-GFRe-CG) >20% from baseline | 12 months (including 9 timepoints) |
| Serum PINP | 12 months (including 5 timepoints) |
| Serum CTX | 12 months (including 5 timepoints) |
| Serum PTH | 12 months (including 9 timepoints) |
Countries
Finland
Outcome results
None listed