Daily Vitamin D Supplementation Compared to a Loading Dose and Monthly Supplementation in Elderly Nursing Home Residents (VIDIV)
This study has been completed.
Sponsor:
Rijnstate Hospital
Information provided by:
Rijnstate Hospital
ClinicalTrials.gov Identifier:
NCT01168544
First received: July 22, 2010
Last updated: January 3, 2013
Last verified: January 2013
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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
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 Vitamin D Ergocalciferols |
Vitamins Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 16, 2013