| - candidate number | 2490 |
| - NTR Number | NTR918 |
| - ISRCTN | ISRCTN33988275 |
| - 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. |
| - ACRONYM | |
| - 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 |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Placebo |
| - group | Parallel |
| - Type | - |
| - Studytype | intervention |
| - 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 3. Falls |
| - Timepoints | |
| - Trial web site | |
| - status | planned |
| - 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 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 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl