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NCT Number: NCT01168544

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alysis Zorggroep, verpleeghuis zevenaar

Zevenaar, Gelderland, 6900 GA, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

loading dose Vitamin D and 50.000 IU vit D3/month

Dietary Supplement

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

loading dose and 25.000 IU vit D3/month

Dietary Supplement

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

Vitamin D 800 IU /day

Dietary Supplement

800 IU vit D3/day

Primary outcomes

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

Secondary outcomes

  1. Proportion of patients reaching a serum 25(OH)D level > 220 nmol/l

  2. Handgrip strength

  3. Distance achieved in a 2 minute walk test

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Registry information

Official study title

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

Acronym: VIDIV

Important dates

Study start
2011
First posted
Jul 23, 2010
Registry last updated
Jan 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.