A Study on Oral Vitamin D Megadoses

NCT ID: NCT01067898

Last Updated: 2012-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-05-31

Brief Summary

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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

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Conditions

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Hypovitaminosis D

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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200 000 IU vitamin D3 every three months

Group Type EXPERIMENTAL

vitamin D3 (cholecalciferol)

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

1000 mg calcium per os every day for one year

100 000 IU vitamin D3 every three months

Group Type EXPERIMENTAL

vitamin D3 (cholecalciferol)

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type OTHER

10 ml (placebo group) or 5 ml (100 000 IU vitamin D3 group) oil per os every three months for one year

calcium carbonate

Intervention Type DIETARY_SUPPLEMENT

1000 mg calcium per os every day for one year

placebo every three months

Group Type PLACEBO_COMPARATOR

olive oil

Intervention Type OTHER

10 ml (placebo group) or 5 ml (100 000 IU vitamin D3 group) oil per os every three months for one year

calcium carbonate

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type DIETARY_SUPPLEMENT

olive oil

10 ml (placebo group) or 5 ml (100 000 IU vitamin D3 group) oil per os every three months for one year

Intervention Type OTHER

calcium carbonate

1000 mg calcium per os every day for one year

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Vigantol vitamin D3 (cholecalciferol) oil 20 000 IU/ml

Eligibility Criteria

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Inclusion Criteria

* female
* 70-80 yrs old

Exclusion Criteria

* disease or medication affecting calcium homeostasis
* renal failure (Pt-GFRe-CG \< 35 ml/min)
Minimum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ville-Valtteri Välimäki

MD,PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Division of Endocrinology, Department of Medicine, Helsinki University Central Hospital

Helsinki, , Finland

Site Status

Countries

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Finland

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.

Reference Type BACKGROUND
PMID: 19486025 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17136043 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14715830 (View on PubMed)

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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