NCT00575835

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2007

Completed
Last Updated

January 8, 2008

Status Verified

December 1, 2007

First QC Date

December 17, 2007

Last Update Submit

December 26, 2007

Conditions

Optimal Vitamin D Administration

Keywords

vitamin Dseasonal variationPTHbone markers

Outcome Measures

Primary Outcomes (1)

  • Blood 25 OH D vitamin concentrations

    8 times during the year

Secondary Outcomes (1)

  • serum calcium, 24-hour calcium excretion in urine, creatinine clearance

    8 times during the year

Study Arms (2)

1

ACTIVE COMPARATOR
Dietary Supplement: vitamin D twice daily

2

EXPERIMENTAL
Dietary Supplement: Vitamin D3 oil three times in a year

Interventions

vitamin D twice dailyDIETARY_SUPPLEMENT

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

1
Vitamin D3 oil three times in a yearDIETARY_SUPPLEMENT

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

2

Eligibility Criteria

Age70 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Females
  • years
  • Living in the community

You may not qualify if:

  • Renal disease
  • Diseases that contraindicate vitamin D supplementation
  • Medications affecting bone
  • Malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Helsinki, 00029 HUS, Finland

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 17, 2007

First Posted

December 18, 2007

Study Start

October 1, 2006

Study Completion

October 1, 2007

Last Updated

January 8, 2008

Record last verified: 2007-12

Locations

FI(1)