Oral Vitamin D Supplementation in Elderly Women

NCT ID: NCT00575835

Last Updated: 2008-01-08

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

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-10-31

Brief Summary

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The aim of this study is to compare oral vitamin D supplementation administered in two different ways, namely either twice a day (800IU/d, 292000IU/y) or three times a year (97333IU every 4 months, 292000IU/y) in elderly women in combination with daily supplementation of calcium 1 gram. We will 1)compare the blood concentrations of 25 OH vitamin D in the two treatment groups amd monitor if a sufficient and safe concentration of 25OH D in blood can be maintained with these two treatments.2) Find out seasonal variation in vitamin D concentrations in these treatments. 3) Find out safety of these treatments

Detailed Description

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Conditions

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Optimal Vitamin D Administration

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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1

Group Type ACTIVE_COMPARATOR

vitamin D twice daily

Intervention Type DIETARY_SUPPLEMENT

Kalsipos-D, vitamin D3 400 ID/tbl, 2 tbl/day for one year

2

Group Type EXPERIMENTAL

Vitamin D3 oil three times in a year

Intervention Type DIETARY_SUPPLEMENT

Vigantol oil , D3 20000IU/ml, 4.9 ml every four months for one year

Interventions

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vitamin D twice daily

Kalsipos-D, vitamin D3 400 ID/tbl, 2 tbl/day for one year

Intervention Type DIETARY_SUPPLEMENT

Vitamin D3 oil three times in a year

Vigantol oil , D3 20000IU/ml, 4.9 ml every four months for one year

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Females
* 70-80 years
* Living in the community

Exclusion Criteria

* Renal disease
* Diseases that contraindicate vitamin D supplementation
* Medications affecting bone
* Malignancy
Minimum Eligible Age

70 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Päivikki and Sakari Sohlberg Foundation, Finland

OTHER

Sponsor Role collaborator

Lilly Foundation

UNKNOWN

Sponsor Role collaborator

University of Helsinki

OTHER

Sponsor Role lead

Responsible Party

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

Locations

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Helsinki University Central Hospital, department of medicine, division of endocrinology

Helsinki, , Finland

Site Status

Countries

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Finland

Other Identifiers

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77/2006

Identifier Type: -

Identifier Source: org_study_id

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