Oral Vitamin D Supplementation in Elderly Women | NCT00575835

Studies
Oral Vitamin D Supplementation in Elderly Women

NCT00575835

Sponsor

University of Helsinki

Status

Completed

Last Update Posted

Jan 8, 2008Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Optimal Vitamin D Administration

Interventions

vitamin D twice daily
Vitamin D3 oil three times in a year

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2006

Primary Completion Date

Not provided

Completion Date

Oct 2007Actual

First Submitted Date

Dec 17, 2007

First Submission Date that Met QC Criteria

Dec 17, 2007

First Posted Date

Dec 18, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 26, 2007

Last Update Posted Date

Jan 8, 2008Estimated

Name	Class
Päivikki and Sakari Sohlberg Foundation, Finland	OTHER
Lilly Foundation	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator		Dietary Supplement: vitamin D twice daily
2	Experimental		Dietary Supplement: Vitamin D3 oil three times in a year

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vitamin D twice daily	Dietary Supplement	Kalsipos-D, vitamin D3 400 ID/tbl, 2 tbl/day for one year	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood 25 OH D vitamin concentrations		8 times during the year

Secondary Outcomes

Measure	Description	Time Frame
serum calcium, 24-hour calcium excretion in urine, creatinine clearance		8 times during the year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Females
70-80 years
Living in the community

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

80 Years

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helsinki University Central Hospital, department of medicine, division of endocrinology		Helsinki		00029 HUS	Finland