Oral Vitamin D Supplementation in Elderly Women

Sponsor

University of Helsinki (Other)

Overall Status

Completed

CT.gov ID

NCT00575835

Collaborator

Päivikki and Sakari Sohlberg Foundation, Finland (Other), Lilly Foundation (Other)

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Optimal Vitamin D Administration	Dietary Supplement: vitamin D twice daily Dietary Supplement: Vitamin D3 oil three times in a year	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Oral Vitamin D Supplementation in Elderly Women: Twice a Day or Three Times a Year? A Randomised Controlled Trial

Study Start Date :

Oct 1, 2006

Actual Study Completion Date :

Oct 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1	Dietary Supplement: vitamin D twice daily Kalsipos-D, vitamin D3 400 ID/tbl, 2 tbl/day for one year
Experimental: 2	Dietary Supplement: Vitamin D3 oil three times in a year Vigantol oil , D3 20000IU/ml, 4.9 ml every four months for one year

Arm

Intervention/Treatment

Active Comparator: 1

Dietary Supplement: vitamin D twice daily

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

Experimental: 2

Dietary Supplement: Vitamin D3 oil three times in a year

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

Outcome Measures

Primary Outcome Measures

Blood 25 OH D vitamin concentrations [8 times during the year]

Secondary Outcome Measures

serum calcium, 24-hour calcium excretion in urine, creatinine clearance [8 times during the year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Females
70-80 years
Living in the community

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Helsinki University Central Hospital, department of medicine, division of endocrinology	Helsinki		Finland	00029 HUS

Sponsors and Collaborators

University of Helsinki
Päivikki and Sakari Sohlberg Foundation, Finland
Lilly Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00575835

Other Study ID Numbers:

77/2006

First Posted:

Dec 18, 2007

Last Update Posted:

Jan 8, 2008

Last Verified:

Dec 1, 2007

Keywords provided by , ,

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 8, 2008