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CompletedNCT00575835Updated Jan 8, 2008

Oral Vitamin D Supplementation in Elderly Women

An interventional study of vitamin D twice daily and Vitamin D3 oil three times in a year in Optimal Vitamin D Administration, sponsored by University of Helsinki. Completed at 1 site in Finland. Open to female participants aged 70 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-01-08.

Sponsored by University of Helsinki · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
70 Years to 80 Years
Sex
Female
01

Study 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

02

Conditions studied

  • Optimal Vitamin D Administration

Keywords

  • vitamin D
  • seasonal variation
  • PTH
  • bone markers
03

In context

Lead sponsor

University of Helsinki is the lead sponsor of 129 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Renal disease
  • Diseases that contraindicate vitamin D supplementation
  • Medications affecting bone
  • Malignancy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    1

    Dietary Supplement: vitamin D twice daily

  • Experimental
    2

    Dietary Supplement: Vitamin D3 oil three times in a year

Interventions

  • Dietary supplementvitamin D twice daily

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

  • Dietary supplementVitamin D3 oil three times in a year

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

06

What researchers measure

Primary outcomes

  1. Blood 25 OH D vitamin concentrations

    Time frame: 8 times during the year

Secondary outcomes

  1. serum calcium, 24-hour calcium excretion in urine, creatinine clearance

    Time frame: 8 times during the year

07

Study locations

1 site
  • Helsinki University Central Hospital, department of medicine, division of endocrinology
    Helsinki, 00029 HUS, Finland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00575835
Lead sponsor
University of Helsinki
Collaborators
Päivikki and Sakari Sohlberg Foundation, Finland, Lilly Foundation
First posted
Dec 18, 2007
Start date
Oct 2006
Completion
Oct 2007
Last update
Jan 8, 2008

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2007. You cannot join it, but the record below documents what was studied.

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