Primairy aim:-to investigate whether with a loading dose based on body weight and baseline serum 25(OH)D level more patients achieve adequate serum 25(OH)D levels compared to 800 IU a day on T 1( 5 weeks) and T2 (12 weeks).-to determine the best…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Vitamine deficienties
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Proportion of patients achieving and maintaining an adequate serum 25(OH)D
level (75 -150 nmol/l).
Secondary outcome
Proportion of patients developing a serum 25(OH)D level > 220 nmol/l.
Percentage of patients achieving an adequate serum 25(OH)D level, with the use
of a loading dose, after 5 weeks
Handgrip strength.
Distance achieved in a 2 minute walk test.
Background summary
Vitamin D deficiency is common in older persons, in particular in residents of
nursing homes. This is mainly explained by the fact that older persons do not
often go outside in the sunshine. On top of that the capacity of the skin to
synthesize provitamin D is decreased and dietary vitamin D intake is low.
Vitamin D deficiency leads to osteoporosis, falls and fractures. To prevent
morbidity and mortality due to falls and fractures it seems logical to
supplement vit D in order to correct the deficiency. The advised daily dose of
vit D supplementation is 800 IU. Several studies showed that with this dose the
required serum 25(OH)D levels will not be reached.
Study objective
Primairy aim:
-to investigate whether with a loading dose based on body weight and baseline
serum 25(OH)D level more patients achieve adequate serum 25(OH)D levels
compared to 800 IU a day on T 1( 5 weeks) and T2 (12 weeks).
-to determine the best consolidation treatment.
Secondairy aim:
-is a loading dose based on body weight and baseline serum 25(OH)D level safe
to use in residents of nursing homes.
-is there a relation between the increase in serum 25(OH)D level and muscle
strength (handgrip strength).
-is there a relation between the increase in serum 25(OH)D level and mobility
(2 minute walk test).
-how many patients reach adequate vit D levels, with the use off a loading,
dose after 5 weeks.
Study design
Randomised trial with 3 study groups:
Group 1a. loading dose based on body weight and baseline serum 25(OH)D level +
50.000 IU vit D3/month consolidation therapy.
Groep 1b. loading dose based on body weight and baseline serum 25(OH)D level +
25.000 IU vit D3/month consolidation therapy.
Groep 2. 800 IU vit D3/ dag.
Intervention
Group 1a. loading dose based on body weight and baseline serum 25(OH)D level +
50.000 IU vit D3/month consolidation therapy.
Groep 1b. loading dose based on body weight and baseline serum 25(OH)D level +
25.000 IU vit D3/month consolidation therapy.
Groep 2. 800 IU vit D3/ dag.
Study burden and risks
Patient time: 120 minutes in a period of 6 months, including one visit to the
outpatient clinic.
Tests: hand grip strengt and 2 minute walking test will be assessed 4 times.
Blood will be drawn 4 times.
Postbus 9000
6900 GA Zevenaar
NL
Postbus 9000
6900 GA Zevenaar
NL
Listed location countries
Age
Inclusion criteria
Long term indication for living in a residential home for the elderly
Age > 65 years
Vitamin D deficiency (serum 25- hydroxycholecholecalciferol (25(OH) D3 < 50 nmol/l)
Informed consent
Exclusion criteria
Hypercalcemia (serum Ca > 2.60 mmol/l)
Hyperfosfatemia (serum PO4>2.0 mmol/l)
Ca x PO4 > 4.5
Life expectancy < 1/2 year
Multivitamin use including > 400 IE vit D
Renal dysfunction GFR< 30ml/min
malabsorption
granulomatous disease (tubercolusis, sarcoidosis)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL32764.091.10 |