A Study on Oral Vitamin D Megadoses

Hypovitaminosis D Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled Study on Oral Vitamin D Megadoses - 100 000 or 200 000 IU Vitamin D3 Every Three Months

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01067898
• Other study ID #: HUS-S-D-II
• Secondary ID: 2009-018139-98KL
• Status: Completed
• Phase: Phase 4
• First received: February 11, 2010
• Last updated: March 26, 2012
• Start date: February 2010
• Est. completion date: May 2011

Study information

• Verified date: March 2012
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines AgencyFinland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• female

• 70-80 yrs old

Exclusion Criteria:

• disease or medication affecting calcium homeostasis

• renal failure (Pt-GFRe-CG < 35 ml/min)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Avitaminosis
• Hypovitaminosis D
• Rickets
• Vitamin D Deficiency

Intervention

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:
• 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

Locations

Country	Name	City	State
Finland	Division of Endocrinology, Department of Medicine, Helsinki University Central Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (3)

Pekkarinen T, Välimäki VV, Aarum S, Turpeinen U, Hämäläinen E, Löyttyniemi E, Välimäki 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum 25(OH)D3 concentration in relation to the target levels of 50-75 nmol/L		12 months (including 9 time points)	No
Secondary	Decline of creatine clearance (Pt-GFRe-CG) >20% from baseline		12 months (including 9 timepoints)	Yes
Secondary	Hypercalciuria (dU-Ca >10 mmol/24h)		12 months (including 9 timepoints)	Yes
Secondary	Hypercalcemia (S-Ca-ion >1,3 mmol/l)		12 months (including 9 timepoints)	Yes
Secondary	Serum PTH		12 months (including 9 timepoints)	No
Secondary	Serum PINP		12 months (including 5 timepoints)	No
Secondary	Serum CTX		12 months (including 5 timepoints)	No