A Study on Oral Vitamin D Megadoses

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Ville-Valtteri Välimäki, Helsinki University Central Hospital

ClinicalTrials.gov Identifier:

NCT01067898

First received: February 11, 2010

Last updated: March 26, 2012

Last verified: March 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	February 11, 2010
Last Updated Date	March 26, 2012
Start Date ^ICMJE	February 2010
Primary Completion Date	May 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 11, 2010)	Serum 25(OH)D3 concentration in relation to the target levels of 50-75 nmol/L [ Time Frame: 12 months (including 9 time points) ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01067898 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 11, 2010)	Decline of creatine clearance (Pt-GFRe-CG) >20% from baseline [ Time Frame: 12 months (including 9 timepoints) ] [ Designated as safety issue: Yes ] Hypercalciuria (dU-Ca >10 mmol/24h) [ Time Frame: 12 months (including 9 timepoints) ] [ Designated as safety issue: Yes ] Hypercalcemia (S-Ca-ion >1,3 mmol/l) [ Time Frame: 12 months (including 9 timepoints) ] [ Designated as safety issue: Yes ] Serum PTH [ Time Frame: 12 months (including 9 timepoints) ] [ Designated as safety issue: No ] Serum PINP [ Time Frame: 12 months (including 5 timepoints) ] [ Designated as safety issue: No ] Serum CTX [ Time Frame: 12 months (including 5 timepoints) ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study on Oral Vitamin D Megadoses
Official Title ^ICMJE	A Randomized, Double-blind, Placebo-controlled Study on Oral Vitamin D Megadoses - 100 000 or 200 000 IU Vitamin D3 Every Three Months
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Hypovitaminosis D
Intervention ^ICMJE	Dietary Supplement: 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. Other Name: Vigantol vitamin D3 (cholecalciferol) oil 20 000 IU/ml Other: olive oil 10 ml (placebo group) or 5 ml (100 000 IU vitamin D3 group) oil per os every three months for one year Dietary Supplement: calcium carbonate 1000 mg calcium per os every day for one year
Study Arm (s)	Experimental: 200 000 IU vitamin D3 every three months Interventions: Dietary Supplement: vitamin D3 (cholecalciferol) Dietary Supplement: calcium carbonate Experimental: 100 000 IU vitamin D3 every three months Interventions: Dietary Supplement: vitamin D3 (cholecalciferol) Other: olive oil Dietary Supplement: calcium carbonate Placebo Comparator: placebo every three months Interventions: Other: olive oil Dietary Supplement: calcium carbonate
Publications *	Pekkarinen T, Välimäki VV, Aarum S, Turpeinen U, Hämäläinen E, Löyttyniemi E, Välimäki MJ. The same annual dose of 292 000 IU of vitamin D(3) (cholecalciferol) on either daily or four monthly basis for elderly women: 1-year comparative study of the effects on serum 25(OH)D(3) concentrations and renal function. Clin Endocrinol (Oxf). 2009 May 25; [Epub ahead of print] Välimäki VV, Löyttyniemi E, Välimäki 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. Epub 2006 Nov 29. Välimäki VV, Alfthan H, Lehmuskallio E, Löyttyniemi E, Sahi T, Stenman UH, Suominen H, Välimäki 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	60
Completion Date	May 2011
Primary Completion Date	May 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: female 70-80 yrs old Exclusion Criteria: disease or medication affecting calcium homeostasis renal failure (Pt-GFRe-CG < 35 ml/min)
Gender	Female
Ages	70 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Finland

Administrative Information
NCT Number ^ICMJE	NCT01067898
Other Study ID Numbers ^ICMJE	HUS-S-D-II, 2009-018139-98, KLnro 1/2010
Has Data Monitoring Committee	No
Responsible Party	Ville-Valtteri Välimäki, Helsinki University Central Hospital
Study Sponsor ^ICMJE	Helsinki University Central Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Helsinki University Central Hospital
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top