Daily Vitamin D Supplementation Compared to a Loading Dose and Monthly Supplementation in Elderly Nursing Home Residents

Study Overview
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Brief Summary
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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: 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.

Official Title
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Vitamin D Supplementation in Elderly Nursing Home Residents: Daily Supplementation Compared to a Loading Dose an Monthly Supplementation, a Randomised Trial

Conditions
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Vitamin D Deficiency in Older Persons

Intervention / Treatment
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* Dietary Supplement: loading dose Vitamin D and 50.000 IU vit D3/month
* Dietary Supplement: loading dose and 25.000 IU vit D3/month
* Dietary Supplement: Vitamin D 800 IU /day


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: loading dose and 50.000 IU vit D3/month<br>Loading dose based on body weight and baseline serum 25 (OH)D level + 50.000 IU vit D3/month consolidation | Dietary Supplement: loading dose Vitamin D and 50.000 IU vit D3/month<br>* loading dose based on body weight and baseline serum 25(OH)D level + 50.000 IU vit D3/month consolidation therapy<br>|
| Experimental: Loading dose and 25.000 IU vit D3/month<br>Loading dose based on body weight and baseline serum 25(OH)D level + 25.000 IU vit D3/month consolidation therapy | Dietary Supplement: loading dose and 25.000 IU vit D3/month<br>* loading dose based on body weight and baseline serum 25(OH)D level + 25.000 IU vit D3/month consolidation therapy<br>|
| Active Comparator: 800 IU vit D3/dag<br>800 IU vit D3/dag | Dietary Supplement: Vitamin D 800 IU /day<br>* 800 IU vit D3/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients reaching an adequate serum 25(OH)D level (75-150 nmol/l) |  |  | 

Secondary Outcome Measures

| Outcome Measure | 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, Colecalciferol, Nursing home, Loading dose