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

This study has been completed.
Sponsor:
Information provided by:
Rijnstate Hospital
ClinicalTrials.gov Identifier:
NCT01168544
First received: July 22, 2010
Last updated: January 3, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Vitamin D Deficiency in Older Persons
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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vitamin D Supplementation in Elderly Nursing Home Residents: Daily Supplementation Compared to a Loading Dose an Monthly Supplementation, a Randomised Trial

Resource links provided by NLM:


Further study details as provided by Rijnstate Hospital:

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

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

Estimated Enrollment: 160
Study Start Date: May 2011
Arms Assigned Interventions
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
800 IU vit D3/dag
Dietary Supplement: Vitamin D 800 IU /day
800 IU vit D3/day

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01168544

Locations
Netherlands
Alysis Zorggroep, verpleeghuis zevenaar
Zevenaar, Gelderland, Netherlands, 6900 GA
Sponsors and Collaborators
Rijnstate Hospital
Investigators
Principal Investigator: D.T.W. Salemink, Drs. Alysis Zorggroep
  More Information

No publications provided

Responsible Party: Mw. D.T.W. Salemink, Alysis Zorggroep
ClinicalTrials.gov Identifier: NCT01168544     History of Changes
Other Study ID Numbers: LTC 712-050710
Study First Received: July 22, 2010
Last Updated: January 3, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Rijnstate Hospital:
Vitamin D
Colecalciferol
Nursing home
Loading dose

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on October 19, 2014