Study Results
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Basic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2010-02-28
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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200 000 IU vitamin D3 every three months
vitamin 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.
calcium carbonate
1000 mg calcium per os every day for one year
100 000 IU vitamin D3 every three months
vitamin 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.
olive oil
10 ml (placebo group) or 5 ml (100 000 IU vitamin D3 group) oil per os every three months for one year
calcium carbonate
1000 mg calcium per os every day for one year
placebo every three months
olive oil
10 ml (placebo group) or 5 ml (100 000 IU vitamin D3 group) oil per os every three months for one year
calcium carbonate
1000 mg calcium per os every day for one year
Interventions
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vitamin 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.
olive oil
10 ml (placebo group) or 5 ml (100 000 IU vitamin D3 group) oil per os every three months for one year
calcium carbonate
1000 mg calcium per os every day for one year
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 70-80 yrs old
Exclusion Criteria
* renal failure (Pt-GFRe-CG \< 35 ml/min)
70 Years
FEMALE
Yes
Sponsors
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Helsinki University Central Hospital
OTHER
Responsible Party
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Ville-Valtteri Välimäki
MD,PhD
Locations
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Division of Endocrinology, Department of Medicine, Helsinki University Central Hospital
Helsinki, , Finland
Countries
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References
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Pekkarinen T, Valimaki VV, Aarum S, Turpeinen U, Hamalainen E, Loyttyniemi E, Valimaki MJ. The same annual dose of 292000 IU of vitamin D (cholecalciferol) on either daily or four monthly basis for elderly women: 1-year comparative study of the effects on serum 25(OH)D concentrations and renal function. Clin Endocrinol (Oxf). 2010 Apr;72(4):455-61. doi: 10.1111/j.1365-2265.2009.03637.x. Epub 2009 May 25.
Valimaki VV, Loyttyniemi E, Valimaki MJ. Vitamin D fortification of milk products does not resolve hypovitaminosis D in young Finnish men. Eur J Clin Nutr. 2007 Apr;61(4):493-7. doi: 10.1038/sj.ejcn.1602550. Epub 2006 Nov 29.
Valimaki VV, Alfthan H, Lehmuskallio E, Loyttyniemi E, Sahi T, Stenman UH, Suominen H, Valimaki MJ. Vitamin D status as a determinant of peak bone mass in young Finnish men. J Clin Endocrinol Metab. 2004 Jan;89(1):76-80. doi: 10.1210/jc.2003-030817.
Other Identifiers
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2009-018139-98
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
KLnro 1/2010
Identifier Type: OTHER
Identifier Source: secondary_id
HUS-S-D-II
Identifier Type: -
Identifier Source: org_study_id
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