Trial | NCT01168544  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    vitamin d3 ...

  • Study Participants

    160
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.
Study Started
May 31
2011
Last Update
Jan 04
2013
Estimate

Dietary Supplement loading dose Vitamin D and 50.000 IU vit D3/month

loading dose based on body weight and baseline serum 25(OH)D level + 50.000 IU vit D3/month consolidation therapy

Dietary Supplement loading dose and 25.000 IU vit D3/month

loading dose based on body weight and baseline serum 25(OH)D level + 25.000 IU vit D3/month consolidation therapy

Dietary Supplement Vitamin D 800 IU /day

800 IU vit D3/day

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

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
No Results Posted