Vitamin D Deficiency in Older Persons Clinical Trial
— VIDIVOfficial title:
Vitamin D Supplementation in Elderly Nursing Home Residents: Daily Supplementation Compared to a Loading Dose an Monthly Supplementation, a Randomised Trial
| NCT number | NCT01168544 |
| Other study ID # | LTC 712-050710 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | July 22, 2010 |
| Last updated | January 3, 2013 |
| Start date | May 2011 |
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.
primary objective of this study is:
- to investigate whether with a loading dose based on body weight and baseline serum
25(OH)D level more patients reach adequate serum 25(OH)D levels compared to 800 IU a
day.
- to determine the best consolidation treatment.
Secondary objective
- 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).
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.
- Group 1b. loading dose based on body weight and baseline serum 25(OH)D level + 25.000
IU vit D3/month consolidation therapy.
- Group 2. 800 IU vit D3/ dag.
Study population:
Vitamine D deficient residents of nursing homes, 65 years or older.
| Status | Completed |
| Enrollment | 160 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 65 Years and older |
| Eligibility |
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) - Life expectancy < 1/2 year - Multivitamin use including > 400 IE vit D - Non-functional dominant arm |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Alysis Zorggroep, verpleeghuis zevenaar | Zevenaar | Gelderland |
| Lead Sponsor | Collaborator |
|---|---|
| Rijnstate Hospital |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of patients reaching an adequate serum 25(OH)D level (75-150 nmol/l) | |||
| Secondary | Proportion of patients reaching a serum 25(OH)D level > 220 nmol/l | |||
| Secondary | Handgrip strength | |||
| Secondary | Distance achieved in a 2 minute walk test |