Clinical trial NCT01168544: Daily Vitamin D Supplementation Compared to a Loading Dose and Monthly Supplementation in Elderly Nursing Home Residents
Official title: Vitamin D Supplementation in Elderly Nursing Home Residents: Daily Supplementation Compared to a Loading Dose an Monthly Supplementation, a Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vitamin D Deficiency in Older Persons
Keywords: Vitamin D
Colecalciferol
Nursing home
Loading dose
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2010-07-23
Enrollment: 160
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients reaching an adequate serum 25(OH)D level (75-150 nmol/l)
Secondary outcomes:
measure: Proportion of patients reaching a serum 25(OH)D level > 220 nmol/l
measure: Handgrip strength
measure: Distance achieved in a 2 minute walk test
Other outcomes:
Locations:
city: Zevenaar
country: Netherlands
facility: Alysis Zorggroep, verpleeghuis zevenaar
state: Gelderland
Study officials:
affiliation: Alysis Zorggroep
name: D.T.W. Salemink, Drs.
role: PRINCIPAL_INVESTIGATOR
References: