A Phase 4 interventional study of vitamin D3 (cholecalciferol) and olive oil in Hypovitaminosis D, sponsored by Helsinki University Central Hospital. Completed at 1 site in Finland. Open to female participants aged 70 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-03-27.
Sponsored by Helsinki University Central Hospital · Phase 4, Interventional, and Treatment
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.
92 studies on the registry are indexed under Rickets; 5 are open to participants now.
This study's enrollment of 60 is above the median of 53 across 62 interventional studies indexed under Rickets.
Browse Rickets studies →Helsinki University Central Hospital is the lead sponsor of 299 studies on the registry; 60 are open to participants now.
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Exclusion Criteria:
Dietary Supplement: vitamin D3 (cholecalciferol) · Dietary Supplement: calcium carbonate
Dietary Supplement: vitamin D3 (cholecalciferol) · Other: olive oil · Dietary Supplement: calcium carbonate
Other: olive oil · Dietary Supplement: calcium carbonate
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.
Also known as: Vigantol vitamin D3 (cholecalciferol) oil 20 000 IU/ml
10 ml (placebo group) or 5 ml (100 000 IU vitamin D3 group) oil per os every three months for one year
1000 mg calcium per os every day for one year
Serum 25(OH)D3 concentration in relation to the target levels of 50-75 nmol/L
Time frame: 12 months (including 9 time points)
Decline of creatine clearance (Pt-GFRe-CG) >20% from baseline
Time frame: 12 months (including 9 timepoints)
Hypercalciuria (dU-Ca >10 mmol/24h)
Time frame: 12 months (including 9 timepoints)
Hypercalcemia (S-Ca-ion >1,3 mmol/l)
Time frame: 12 months (including 9 timepoints)
Serum PTH
Time frame: 12 months (including 9 timepoints)
Serum PINP
Time frame: 12 months (including 5 timepoints)
Serum CTX
Time frame: 12 months (including 5 timepoints)
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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Helsinki University Central Hospital