Vitamin D Deficiency in Older PersonsPhase 3VIDIVNCT01168544
Daily Vitamin D Supplementation Compared to a Loading Dose and Monthly Supplementation in Elderly Nursing Home Residents
A Phase 3 study testing loading dose Vitamin D and 50.000 IU vit D3/month, loading dose and 25.000 IU vit D3/month and Vitamin D 800 IU /day in people with Vitamin D Deficiency in Older Persons, run by Rijnstate Hospital at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Vitamin D Deficiency in Older Persons
- What is being tested?
- loading dose Vitamin D and 50.000 IU vit D3/month, loading dose and 25.000 IU vit D3/month and Vitamin D 800 IU /day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2011to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Hypercalcemia (serum CA > 2.60 mmol/l)
- Life expectancy < 1/2 year
- Multivitamin use including > 400 IE vit D
- Non-functional dominant arm
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Alysis Zorggroep, verpleeghuis zevenaar
Zevenaar, Gelderland, 6900 GA
About this study
Official title: 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:
Read more
- 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.
- Conditions
- Vitamin D Deficiency in Older Persons
- Being tested
- loading dose Vitamin D and 50.000 IU vit D3/month, loading dose and 25.000 IU vit D3/month, Vitamin D 800 IU /day
- Keywords
- Vitamin D, Colecalciferol, Nursing home, Loading dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
loading dose Vitamin D and 50.000 IU vit D3/monthDietary 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/monthDietary 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 /dayDietary supplement
800 IU vit D3/day
| Study group | Role | What they receive |
|---|---|---|
| loading dose and 50.000 IU vit D3/month | Experimental | Loading dose based on body weight and baseline serum 25 (OH)D level + 50.000 IU vit D3/month consolidation Receives: Dietary Supplement: loading dose Vitamin D and 50.000 IU vit D3/month |
| Loading dose and 25.000 IU vit D3/month | Experimental | Loading dose based on body weight and baseline serum 25(OH)D level + 25.000 IU vit D3/month consolidation therapy Receives: Dietary Supplement: loading dose and 25.000 IU vit D3/month |
| 800 IU vit D3/dag | Active comparator | 800 IU vit D3/dag Receives: Dietary Supplement: Vitamin D 800 IU /day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients reaching an adequate serum 25(OH)D level (75-150 nmol/l)
Secondary outcomes (3)
Proportion of patients reaching a serum 25(OH)D level > 220 nmol/l
Handgrip strength
Distance achieved in a 2 minute walk test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2010 (estimated)
- Study startMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D Deficiency in Older PersonsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Investigators
- D.T.W. Salemink, Drs., Principal investigator, Alysis Zorggroep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01168544
- Sponsor's protocol ID
- LTC 712-050710
- Acronym
- VIDIV
- Status last verified
- Jan 2013
- First submitted
- 22 Jul 2010
- Last updated
- 4 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Supplementation in Elderly Nursing Home Residents: Daily Supplementation Compared to a Loading Dose an Monthly Supplementation, a Randomised Trial
- ClinicalTrials.gov ID
- NCT01168544
- Acronym / sponsor ID
- VIDIV / LTC 712-050710
- Conditions
- Vitamin D Deficiency in Older Persons
- Keywords
- Vitamin D, Colecalciferol, Nursing home, Loading dose
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- May 2011
- First posted
- 23 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| loading dose and 50.000 IU vit D3/month | Experimental | Dietary Supplement: loading dose Vitamin D and 50.000 IU vit D3/monthLoading 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 | Experimental | Dietary Supplement: loading dose and 25.000 IU vit D3/monthLoading 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 | Active comparator | Dietary Supplement: Vitamin D 800 IU /day800 IU vit D3/dag |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Hypercalcemia (serum CA > 2.60 mmol/l)
- Life expectancy < 1/2 year
- Multivitamin use including > 400 IE vit D
- Non-functional dominant arm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| loading dose Vitamin D and 50.000 IU vit D3/monthloading dose based on body weight and baseline serum 25(OH)D level + 50.000 IU vit D3/month consolidation therapy | Dietary supplement | loading dose and 50.000 IU vit D3/month |
| loading dose and 25.000 IU vit D3/monthloading 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 |
| Vitamin D 800 IU /day800 IU vit D3/day | Dietary supplement | 800 IU vit D3/dag |
Primary outcome
Proportion of patients reaching an adequate serum 25(OH)D level (75-150 nmol/l)
3 secondary outcomes
Proportion of patients reaching a serum 25(OH)D level > 220 nmol/l
Handgrip strength
Distance achieved in a 2 minute walk test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
D.T.W. Salemink, Drs. principal investigator
Alysis Zorggroep
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing loading dose Vitamin D and 50.000 IU vit D3/month, loading dose and 25.000 IU vit D3/month and Vitamin D 800 IU /day in people with Vitamin D Deficiency in Older Persons, run by Rijnstate Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients reaching an adequate serum 25(OH)D level (75-150 nmol/l). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2013.