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

Phase 3

Completed

• Conditions: Vitamin D Deficiency in Older Persons
• Interventions: 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

• Registration Number: NCT01168544
• Lead Sponsor: Rijnstate Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-22
• Study First Submitted QC: 2010-07-22
• Study First Posted: 2010-07-23
• Study Start: 2011-05
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-03
• Last Update Posted: 2013-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
loading dose and 50.000 IU vit D3/month	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
Loading dose and 25.000 IU vit D3/month	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
800 IU vit D3/dag	Vitamin D 800 IU /day	800 IU vit D3/dag

Primary Outcome Measures

Name	Time	Method
Proportion of patients reaching an adequate serum 25(OH)D level (75-150 nmol/l)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Alysis Zorggroep, verpleeghuis zevenaar; 🇳🇱 Zevenaar, Gelderland, Netherlands