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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01168544
Acronym
VIDIV
Enrollment
160
Registered
2010-07-23
Start date
2011-05-31
Completion date
Unknown
Last updated
2013-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D Deficiency in Older Persons

Keywords

Vitamin D, Colecalciferol, Nursing home, Loading dose

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.

Interventions

DIETARY_SUPPLEMENTloading 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_SUPPLEMENTloading 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_SUPPLEMENTVitamin D 800 IU /day

800 IU vit D3/day

Sponsors

Rijnstate Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Proportion of patients reaching an adequate serum 25(OH)D level (75-150 nmol/l)

Secondary

MeasureTime frame
Proportion of patients reaching a serum 25(OH)D level > 220 nmol/l
Handgrip strength
Distance achieved in a 2 minute walk test

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026