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Effects of high dose vitamin D suppletion on muscle mass and muscle strength in frail elderly peolple.


- candidate number2490
- NTR NumberNTR918
- ISRCTNISRCTN33988275
- Date ISRCTN created11-apr-2007
- date ISRCTN requested24-mrt-2007
- Date Registered NTR26-feb-2007
- Secondary IDs 
- Public TitleEffects of high dose vitamin D suppletion on muscle mass and muscle strength in frail elderly peolple.
- Scientific TitleEffects of high dose vitamin D suppletion on muscle strength in frail elderly peolple.
- ACRONYM
- hypothesisVitamin D improves muscle-mass and -strength which improves overall quality of life in patients with low serum vitamin D levels.
- Healt Condition(s) or Problem(s) studiedSarcopenia, Frailty, Hypovitaminosis D
- Inclusion criteria1. Frail elderly people, age > 65; 2. Living in homes for the elderly; 3. Serum vitamin D level < 50 nmol/l
- Exclusion criteria1. Not able to perform muscle strength measurements; 2. History of kidney stones, renal insufficiency (<40%); 3. Primary hyperparathyroidism; 4. Dementia (mini mental state examination < 20/30 points; 5. Life expectancy < 6 months; 6. Neurodegenerative disorders (M. Parkinson, ALS); 7. Use of the following medications: vitamin D, bisphosphonates, steroids.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-apr-2007
- planned closingdate1-apr-2008
- Target number of participants300
- InterventionsIndividuals are randomized to recieve either 1200IU vitamin D/day and 1000mg calcium/day or placebo medications and 1000mg calcium/day. Medications will be used for a period of 6 months.
- Primary outcomeDifferences in muscle strength (handgrip strength and m. quadriceps strength) between treatment and control group
- Secondary outcome1. Changes in mobility a. Timed up & go test b. Walking distance 2. Quality of life a. Health assessment questionnaire 3. Falls
- Timepoints
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES C. Oudshoorn
- CONTACT for SCIENTIFIC QUERIES C. Oudshoorn
- Sponsor/Initiator Erasmus Medical Center, Department of Geriatrics
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, Department of Geriatrics
- Publications
- Brief summaryThe effect of high dose vitamin D on muscle strength in frail elderly people. Objective: to test the hypothesis whether high dose vitamin D suppletion in frail elderly people increases muscle strength and function. Study design: single centre, double blind randomized placebo controlled trial with parralell groups. Intervention: participants will be randomized between one group receiving 1200IU vitamin D/day and 1000mg calcium and another group receiving placebo medication and calcium suppletion for a period of 6 months. Primairy endpoint: changes in mucle strength Secondary endpoint: changes in mobility and quality of life.
- Main changes (audit trail)
- RECORD26-feb-2007 - 12-apr-2007


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