Condition category
Musculoskeletal Diseases
Date applied
11/04/2007
Date assigned
11/04/2007
Last edited
07/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr C Oudshoorn

ORCID ID

Contact details

Erasmus Medical Centre
Room D442
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
+31 (0)10 463 5037
c.oudshoorn@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2007-160

Study information

Scientific title

Acronym

Study hypothesis

Vitamin D improves muscle-mass and -strength which improves overall quality of life in patients with low serum vitamin D levels.

Please note that as of 13/07/10 this record was updated to included changes made to the protocol during the planning phase of the trial (i.e. between the time of registration and the beginning of the recruitment phase). All updates can be found in the relevant field with the above update date.

Ethics approval

Added 13/07/10:
The Medical Ethics Review Committee (Medisch Ethische Toetsings Commissie), Erasmus Medical Centre approved on the 24th of July 2007 (ref: MEC-2007-160)

Study design

Randomised placebo controlled parallel group double blind trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Copies of the Investigational Medicinal Product Dossier (IMPD) and 2007 MEC approval are available on request. Please use contact details below.

Condition

Hypovitaminosis D on muscle mass and strength

Intervention

Current information as of 13/07/10:
Patients were randomised to receive either
1. 1800IU cholecalciferol (vitamin D3) daily
2. Placebo daily
Medications were used for a period of six months. The end date for inclusion into this trial was December 2009.

Initial information at time of registration
Individuals are randomised to recieve either:
1. 1200 IU vitamin D/day and 1000 mg calcium/day
2. Placebo medications and 1000 mg calcium/day

Medications will be used for a period of six months.

Intervention type

Supplement

Phase

Not Specified

Drug names

High dose vitamin D

Primary outcome measures

Differences in muscle strength (handgrip strength and quadriceps strength) between treatment and control group.

Secondary outcome measures

1. Changes in mobility:
1.1. Timed up and go test
1.2. Walking distance
2. Quality of life (using the health assessment questionnaire)
3. Falls

Overall trial start date

01/04/2007

Overall trial end date

01/04/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Frail elderly people, aged greater than 65 years
2. Living in homes for the elderly
3. Serum vitamin D level less than 50 nmol/l
Added 07/04/2011:
4: Stable health (including no history of recurrent falling or recent fracture).

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. Not able to perform muscle strength measurements
2. History of kidney stones, renal insufficiency (less than 40%)
3. Primary hyperparathyroidism
4. Dementia (Mini Mental State Examination [MMSE] less than 20/30 points
5. Life expectancy less than six months
6. Neurodegenerative disorders (Parkinsons, Amyotrophic Lateral Sclerosis [ALS])
7. Use of the following medications:
7.1. Vitamin D
7.2. Bisphosphonates
7.3. Steroids

Recruitment start date

01/04/2007

Recruitment end date

01/04/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Centre
Rotterdam
3000 CA
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre (Netherlands)

Sponsor details

Department of Geriatrics
P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.erasmusmc.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Erasmus Medical Centre (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes