Vitamin D DeficiencyPhase 3NCT00681590
Safety of Vitamin D Supplementation in Older Persons
A Phase 3 study testing cholecalciferol (vitamin D) in people with Vitamin D Deficiency, run by University of Miami at 1 site in United States.
Trial summary
This study will evaluate the safety over 6 months of two different doses of vitamin D (cholecalciferol) in men and women age 65 and older. It will also evaluate if supplementation with vitamin D improves physical performance. Read more about this study
- Who is it for?
- Ages 65 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- cholecalciferol (vitamin D)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Apr 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 95 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- ambulatory
Who cannot join
- hypercalcemia
- hypercalciuria > 4 mg/kg body weight/day
- primary, secondary, or tertiary hyperparathyroidism
- renal insufficiency (serum creatinine > 2 mg/dL )
- history of nephrolithiasis
- treatment with vitamin D (ergocalciferol, cholecalciferol, calcitriol)
Show all 11Show fewer
- treatment with anticonvulsants
- Paget's disease
- severe cardiac, pulmonary, hepatic, renal, or neurological disease
- life expectancy < 1 year
- participation in another trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety of Vitamin D Supplementation in the Elderly
This study will evaluate the safety over 6 months of two different doses of vitamin D (cholecalciferol) in men and women age 65 and older. It will also evaluate if supplementation with vitamin D improves physical performance.
Read the detailed description
120 ambulatory men and women ages 65 to 95 will be enrolled in this study. Each subject will participate in the clinical trial for 6 months.
Parathyroid hormone, vitamin D, and serum and urinary calcium will be measured periodically. Physical performance will be tested at baseline and throughout the study.
- Conditions
- Vitamin D Deficiency
- Being tested
- cholecalciferol (vitamin D)
- Keywords
- vitamin D, deficiency, elderly
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholecalciferol (vitamin D)Dietary supplement
400 IU daily (low dose)
cholecalciferol (vitamin D)Dietary supplement
2000 IU daily (high dose)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | vitamin D (cholecalciferol) 400 IU daily orally - low dose Receives: Dietary Supplement: cholecalciferol (vitamin D) |
| 2 | Active comparator | vitamin D (cholecalciferol) 2000 IU daily orally - high dose Receives: Dietary Supplement: cholecalciferol (vitamin D) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Develop Hypercalcemia
calcium serum levels measured at baseline and at the end of the intervention (6-months)
Measured: 6 months
Secondary outcomes (1)
Change From Baseline in Serum 25-hydroxyvitamin D Levels
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Silvina Levis, MD, University of Miami
- Investigators
- Silvina Levis, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681590
- Sponsor's protocol ID
- 20070018
- Status last verified
- Dec 2016
- First submitted
- 15 May 2008
- Last updated
- 26 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lagari V, Gomez-Marin O, Levis S. The role of vitamin D in improving physical performance in the elderly. J Bone Miner Res. 2013 Oct;28(10):2194-201. doi: 10.1002/jbmr.1949.
PubMed 23553992Lagari VS, Gomez-Marin O, Levis S. Differences in vitamin D3 dosing regimens in a geriatric community-dwelling population. Endocr Pract. 2012 Nov-Dec;18(6):847-54. doi: 10.4158/EP12081.OR.
PubMed 22784845
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Vitamin D Supplementation in the Elderly
- ClinicalTrials.gov ID
- NCT00681590
- Acronym / sponsor ID
- 20070018
- Conditions
- Vitamin D Deficiency
- Keywords
- vitamin D, deficiency, elderly
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Apr 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 21 May 2008 (estimated)
- Results
- Posted 7 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety over 6 months of two different doses of vitamin D (cholecalciferol) in men and women age 65 and older. It will also evaluate if supplementation with vitamin D improves physical performance.
Detailed description
120 ambulatory men and women ages 65 to 95 will be enrolled in this study. Each subject will participate in the clinical trial for 6 months.
Parathyroid hormone, vitamin D, and serum and urinary calcium will be measured periodically. Physical performance will be tested at baseline and throughout the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: cholecalciferol (vitamin D)vitamin D (cholecalciferol) 400 IU daily orally - low dose |
| 2 | Active comparator | Dietary Supplement: cholecalciferol (vitamin D)vitamin D (cholecalciferol) 2000 IU daily orally - high dose |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- ambulatory
Key exclusion criteria (11 listed)
- hypercalcemia
- hypercalciuria > 4 mg/kg body weight/day
- primary, secondary, or tertiary hyperparathyroidism
- renal insufficiency (serum creatinine > 2 mg/dL )
- history of nephrolithiasis
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 |
|---|---|---|
| cholecalciferol (vitamin D)400 IU daily (low dose) | Dietary supplement | 1 |
| cholecalciferol (vitamin D)2000 IU daily (high dose) | Dietary supplement | 2 |
Primary outcome
Number of Participants Who Develop Hypercalcemia
Time frame: 6 months
calcium serum levels measured at baseline and at the end of the intervention (6-months)
1 secondary outcome
Change From Baseline in Serum 25-hydroxyvitamin D Levels
Time frame: baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23553992Lagari V, Gomez-Marin O, Levis S. The role of vitamin D in improving physical performance in the elderly. J Bone Miner Res. 2013 Oct;28(10):2194-201. doi: 10.1002/jbmr.1949.
- Results publication: PubMed 22784845Lagari VS, Gomez-Marin O, Levis S. Differences in vitamin D3 dosing regimens in a geriatric community-dwelling population. Endocr Pract. 2012 Nov-Dec;18(6):847-54. doi: 10.4158/EP12081.OR.
- link to Pubmed abstractLink provided by the sponsor.
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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.
Silvina Levis, MD principal investigator
University of Miami
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 cholecalciferol (vitamin D) in people with Vitamin D Deficiency, run by University of Miami at 1 site in United States.
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 1 inclusion and 11 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 26 Jan 2017. 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 United States. 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?
Yes. Results are posted in the registry (first posted 7 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Develop Hypercalcemia (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00681590, which also lists 2 linked publications.
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 26 Jan 2017.