Effects of high dose vitamin D supplementation on muscle mass and muscle strength in frail elderly people
| ISRCTN | ISRCTN33988275 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33988275 |
| Secondary identifying numbers | 2007-160 |
- Submission date
- 11/04/2007
- Registration date
- 11/04/2007
- Last edited
- 07/04/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr C Oudshoorn
Scientific
Scientific
Erasmus Medical Centre
Room D442
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
| Phone | +31 (0)10 463 5037 |
|---|---|
| c.oudshoorn@erasmusmc.nl |
Study information
| Study design | Randomised placebo controlled parallel group double blind trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Copies of the Investigational Medicinal Product Dossier (IMPD) and 2007 MEC approval are available on request. Please use contact details below. |
| Scientific title | |
| Study objectives | 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(s) | 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) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/04/2007 |
| Completion date | 01/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 300 |
| Key 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). |
| Key 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 |
| Date of first enrolment | 01/04/2007 |
| Date of final enrolment | 01/04/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Centre
Rotterdam
3000 CA
Netherlands
3000 CA
Netherlands
Sponsor information
Erasmus Medical Centre (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Geriatrics
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
| Website | http://www.erasmusmc.nl/ |
|---|---|
"ROR" |
https://ror.org/018906e22 |
Funders
Funder type
Hospital/treatment centre
Erasmus Medical Centre (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
