Oral Vitamin D Supplementation in Elderly Women

December 26, 2007 updated by: University of Helsinki

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years to 80 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Active Comparator: 1
Dietary supplement: vitamin D twice daily
Kalsipos-D, vitamin D3 400 ID/tbl, 2 tbl/day for one year

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Helsinki

Collaborators

Päivikki and Sakari Sohlberg Foundation, Finland
Lilly Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

December 17, 2007

First Submitted That Met QC Criteria

December 17, 2007

First Posted (Estimate)

December 18, 2007

Study Record Updates

Last Update Posted (Estimate)

January 8, 2008

Last Update Submitted That Met QC Criteria

December 26, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 77/2006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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