Vitamin D supplementation in elderly nursing home residents: daily supplementation compared to a loading dose and monthly supplementation, a randomised trial
Phase 3
Completed
- Conditions
- Vitamine deficientiesVitamin D deficiency
- Registration Number
- NL-OMON36493
- Lead Sponsor
- iemerije in Zevenaar (verpleeghuis)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Proportion of patients achieving and maintaining an adequate serum 25(OH)D<br /><br>level (75 -150 nmol/l).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Proportion of patients developing a serum 25(OH)D level > 220 nmol/l.<br /><br>Percentage of patients achieving an adequate serum 25(OH)D level, with the use<br /><br>of a loading dose, after 5 weeks<br /><br>Handgrip strength.<br /><br>Distance achieved in a 2 minute walk test.</p><br>