Efficacy of a vitamin D dosing regime
- Conditions
- Vitamin D deficiency, Vitamine D deficiëntie
- Registration Number
- NL-OMON21710
- Lead Sponsor
- Medisch Centrum Leeuwarden
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
The study population comprises residents of 13 somatic and psycho-geriatric nursing homes.
Nursing home residents will be screened for eligibility based on the inclusion criteria. In order to be eligible to participate in this study, a subject must meet all of the following
criteria:
Exclusion Criteria
Not applicable.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary aim of this study is to determine the efficacy of the established cholecalciferol dosing regimen (a single oral loading dose of 200,000 IU cholecalciferol followed by 100,000 IU orally every 13 weeks) in obtaining and maintaining an adequate serum 25-hydroxyvitamin D level between 75 and 220 nmol/L in somatic and psycho-geriatric nursing home residents.
- Secondary Outcome Measures
Name Time Method A second aim of this study is to assess the additional effect of the vitamin D dosing regimen on serum PTH and calcium levels, and to determine the influence of (known) variables as possible effect modifiers on the serum 25-hydroxyvitamin D level outcome.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie cholecalciferol's efficacy in maintaining serum 25-hydroxyvitamin D levels in geriatric populations?
How does the NL-OMON21710 vitamin D regimen compare to standard monthly supplementation in efficacy and safety for nursing home residents?
Which biomarkers correlate with serum 25-hydroxyvitamin D response to high-dose cholecalciferol in elderly patients with somatic/psycho-geriatric conditions?
What adverse events are associated with 200,000 IU cholecalciferol loading doses in vitamin D-deficient elderly populations?
How do vitamin D analogs like calcifediol compare to cholecalciferol in maintaining optimal serum levels in geriatric care settings?