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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:
Secondary objective
Study design:
Randomised trial with 3 study groups:
Study population:
Vitamine D deficient residents of nursing homes, 65 years or older.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| loading dose and 50.000 IU vit D3/month | Experimental | Loading dose based on body weight and baseline serum 25 (OH)D level + 50.000 IU vit D3/month consolidation |
|
| Loading dose and 25.000 IU vit D3/month | Experimental | Loading dose based on body weight and baseline serum 25(OH)D level + 25.000 IU vit D3/month consolidation therapy |
|
| 800 IU vit D3/dag | Active Comparator | 800 IU vit D3/dag |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| loading dose Vitamin D and 50.000 IU vit D3/month | Dietary Supplement | loading dose based on body weight and baseline serum 25(OH)D level + 50.000 IU vit D3/month consolidation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients reaching an adequate serum 25(OH)D level (75-150 nmol/l) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients reaching a serum 25(OH)D level > 220 nmol/l | ||
| Handgrip strength | ||
| Distance achieved in a 2 minute walk test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| D.T.W. Salemink, Drs. | Alysis Zorggroep | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alysis Zorggroep, verpleeghuis zevenaar | Zevenaar | Gelderland | 6900 GA | Netherlands |
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| loading dose and 25.000 IU vit D3/month | Dietary Supplement | loading dose based on body weight and baseline serum 25(OH)D level + 25.000 IU vit D3/month consolidation therapy |
|
| Vitamin D 800 IU /day | Dietary Supplement | 800 IU vit D3/day |
|
| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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