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

January 3, 2013 updated by: Rijnstate Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Zevenaar, Gelderland, Netherlands, 6900 GA
        • Alysis Zorggroep, verpleeghuis zevenaar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: loading dose 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
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
EXPERIMENTAL: 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: 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
ACTIVE_COMPARATOR: 800 IU vit D3/dag
Dietary supplement: Vitamin D 800 IU /day
800 IU vit D3/day

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rijnstate Hospital

Investigators

  • Principal Investigator: D.T.W. Salemink, Drs., Alysis Zorggroep

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Study Registration Dates

First Submitted

July 22, 2010

First Submitted That Met QC Criteria

July 22, 2010

First Posted (ESTIMATE)

July 23, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 4, 2013

Last Update Submitted That Met QC Criteria

January 3, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LTC 712-050710

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vitamin D Deficiency in Older Persons

Clinical Trials on loading dose Vitamin D and 50.000 IU vit D3/month

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe