|- candidate number||2490|
|- NTR Number||NTR918|
|- Date ISRCTN created||11-apr-2007|
|- date ISRCTN requested||24-mrt-2007|
|- Date Registered NTR||26-feb-2007|
|- Secondary IDs|| |
|- Public Title||Effects of high dose vitamin D suppletion on muscle mass and muscle strength in frail elderly peolple.|
|- Scientific Title||Effects of high dose vitamin D suppletion on muscle strength in frail elderly peolple.|
|- hypothesis||Vitamin 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) studied||Sarcopenia, Frailty, Hypovitaminosis D|
|- Inclusion criteria||1. Frail elderly people, age > 65;
2. Living in homes for the elderly;
3. Serum vitamin D level < 50 nmol/l|
|- Exclusion criteria||1. 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 received||no|
|- multicenter trial||no|
|- planned startdate ||1-apr-2007|
|- planned closingdate||1-apr-2008|
|- Target number of participants||300|
|- Interventions||Individuals 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 outcome||Differences in muscle strength (handgrip strength and m. quadriceps strength) between treatment and control group
|- Secondary outcome||1. Changes in mobility
a. Timed up & go test
b. Walking distance
2. Quality of life
a. Health assessment questionnaire
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| C. Oudshoorn|
|- CONTACT for SCIENTIFIC QUERIES|| C. Oudshoorn|
|- Sponsor/Initiator ||Erasmus Medical Center, Department of Geriatrics|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center, Department of Geriatrics|
|- Brief summary||The 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)|
|- RECORD||26-feb-2007 - 12-apr-2007|