|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
Netherlands Trial Register |
|
Last refreshed on:
|
28 April 2013 |
|
Main ID: |
NTR918 |
|
Date of registration:
|
26/02/2007 |
|
Primary sponsor: |
|
|
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. -
|
|
Date of first enrolment:
|
1/4/2007 |
|
Target sample size:
|
300 |
|
Recruitment status: |
pending |
|
URL:
|
http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=918 |
|
Study type:
|
intervention |
|
Study design:
|
Randomised: Yes; Masking: Double; Control: Placebo; Group: Parallel; Type: -
|
|
|
Countries of recruitment
|
|
The Netherlands
| | | | | | | |
|
Contacts
|
|
Name:
|
C.
Oudshoorn |
|
Address:
|
Erasmus MC
PO box 2040
Room D442
3000 CA
Rotterdam
The Netherlands |
|
Telephone:
|
010-4635037 |
|
Email:
|
c.oudshoorn@erasmusmc.nl |
|
Affiliation:
|
|
|
|
Name:
|
C.
Oudshoorn |
|
Address:
|
Erasmus MC
PO box 2040
Room D442
3000 CA
Rotterdam
The Netherlands |
|
Telephone:
|
010-4635037 |
|
Email:
|
c.oudshoorn@erasmusmc.nl |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
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.
Age minimum:
Age maximum:
Gender:
|
|
Health Condition(s) or Problem(s) studied
|
Sarcopenia, Frailty, Hypovitaminosis D
|
|
Intervention(s)
|
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(s)
|
Differences in muscle strength (handgrip strength and m. quadriceps strength) between treatment and control group
|
|
Secondary Outcome(s)
|
1. Changes in mobility
a. Timed up & go test
b. Walking distance
2. Quality of life
a. Health assessment questionnaire
3. Falls
|
|
Secondary ID(s)
|
|
ISRCTN33988275
|
|
Source(s) of Monetary Support
|
|
Erasmus Medical Center, Department of Geriatrics
|
|