Elderly, FrailPhase 1NCT00249704
Randomized Study Of Exercise And Vitamin D In Frail Elderly Subjects
A Phase 1 study testing Vitamin D + Exercise in people with Elderly, Frail, run by Pfizer at 4 sites in United States.
Trial summary
The study will explore multiple mobility function tests as well as functional and neuropsychological tests in elderly subjects at risk for falls and disability, before and after 4-month exercise and/or Vitamin D intervention. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Elderly, Frail
- What is being tested?
- Vitamin D + Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2005to Jan 2008
- Phase
- Phase 1
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Elderly subjects with moderate frailty residing in assisted living facilities.
Who cannot join
- Presence of progressive, unstable chronic disease; hyperparathyroidism, hypercalcemia.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Pfizer Investigational Site
Farmington, Connecticut, 06030-5215
Pfizer Investigational Site
Hyattsville, Maryland, 20782
Pfizer Investigational Site
New York, New York, 10040-3403
Pfizer Investigational Site
Roslindale, Massachusetts, 02131-1011
About this study
Official title: Evaluation of the Effect of a 4-Month Intervention of Exercise and/or Vitamin D on Mobility Function and Strength in Frail Elderly Subjects
The study will explore multiple mobility function tests as well as functional and neuropsychological tests in elderly subjects at risk for falls and disability, before and after 4-month exercise and/or Vitamin D intervention.
Read the detailed description
The study was terminated on 10Jan2008. This was a strategic decision not related to safety, efficacy, or feasibility of trial.
- Conditions
- Elderly, Frail
- Being tested
- Vitamin D + Sham Exercise, Vitamin D Placebo + Exercise, Vitamin D Placebo + Sham Exercise, Vitamin D + Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D + Sham ExerciseDrug
1000 IU per day of Vitamin D + Sham (equivalent to placebo) Exercise
Vitamin D Placebo + ExerciseProcedure or surgery
Vitamin D placebo + Exercise
Vitamin D Placebo + Sham ExerciseProcedure or surgery
Vitamin D placebo + Sham (equivalent to placebo) Exercise
Vitamin D + ExerciseDrug
1000 IU per day of Vitamin D + Exercise
| Study group | Role | What they receive |
|---|---|---|
| C | Experimental | Not described Receives: Procedure: Vitamin D Placebo + Exercise |
| B | Experimental | Not described Receives: Drug: Vitamin D + Sham Exercise |
| A | Experimental | Not described Receives: Drug: Vitamin D + Exercise |
| D | Placebo comparator | Not described Receives: Procedure: Vitamin D Placebo + Sham Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of effect of 4-month exercise and/or Vitamin D intervention on mobility function and strength in frail elderly subjects.
Measured: Throughout trial
Secondary outcomes (1)
Evaluation of utility and variability of mobility function tests and biomarkers, as well as explore the predictors for the exercise and/or Vitamin D intervention response in frail elderly subjects.
Measured: throughout trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2005 (estimated)
- Study startOct 2005
- Study completionJan 2008
Why it stopped: See termination reason in detailed description.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly, FrailStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00249704
- Sponsor's protocol ID
- A9001116
- Status last verified
- Jan 2009
- First submitted
- 3 Nov 2005
- Last updated
- 8 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of a 4-Month Intervention of Exercise and/or Vitamin D on Mobility Function and Strength in Frail Elderly Subjects
- ClinicalTrials.gov ID
- NCT00249704
- Acronym / sponsor ID
- A9001116
- Conditions
- Elderly, Frail
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 64 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Study completion
- Jan 2008 (actual)
- First posted
- 7 Nov 2005 (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.
The study will explore multiple mobility function tests as well as functional and neuropsychological tests in elderly subjects at risk for falls and disability, before and after 4-month exercise and/or Vitamin D intervention.
Detailed description
The study was terminated on 10Jan2008. This was a strategic decision not related to safety, efficacy, or feasibility of trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| C | Experimental | Procedure: Vitamin D Placebo + Exercise |
| B | Experimental | Drug: Vitamin D + Sham Exercise |
| A | Experimental | Drug: Vitamin D + Exercise |
| D | Placebo comparator | Procedure: Vitamin D Placebo + Sham Exercise |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Elderly subjects with moderate frailty residing in assisted living facilities.
Key exclusion criteria (1 listed)
- Presence of progressive, unstable chronic disease; hyperparathyroidism, hypercalcemia.
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 |
|---|---|---|
| Vitamin D + Sham Exercise1000 IU per day of Vitamin D + Sham (equivalent to placebo) Exercise | Drug | B |
| Vitamin D Placebo + ExerciseVitamin D placebo + Exercise | Procedure or surgery | C |
| Vitamin D Placebo + Sham ExerciseVitamin D placebo + Sham (equivalent to placebo) Exercise | Procedure or surgery | D |
| Vitamin D + Exercise1000 IU per day of Vitamin D + Exercise | Drug | A |
Primary outcome
Characterization of effect of 4-month exercise and/or Vitamin D intervention on mobility function and strength in frail elderly subjects.
Time frame: Throughout trial
1 secondary outcome
Evaluation of utility and variability of mobility function tests and biomarkers, as well as explore the predictors for the exercise and/or Vitamin D intervention response in frail elderly subjects.
Time frame: throughout trial
Results and safety
The study was stopped early (reason given: See termination reason in detailed description.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2009.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Elderly, Frail
Recruiting
Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
Frailty Syndrome, Prefrail Elderly
Active, not recruitingObservational study
Association of POCD With Circulating Biomarkers in Patients Undergoing TUR of Bladder Tumor
Cognitive Decline, Urinary Bladder Cancer
Not yet recruitingObservational study
Postprandial Hypotension, Frailty and Post-Induction Hypotension in Older Patients Undergoing Noncardiac Surgery
Post-induction Hypotension (PIH), Postprandial Hypotension
Active, not recruitingPhase 2
Chemoradiotherapy Versus Chemotherapy for Elderly and Frail GBM Patients
Glioblastoma Multiforme
Not yet recruiting
Effect of Animation-Based Digital Education on Risk Knowledge and Frailty in Older Adults
Aging, Frail Elderly
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.
Pfizer CT.gov Call Center study director
Pfizer
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vitamin D + Exercise in people with Elderly, Frail, run by Pfizer at 4 sites 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 1 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: stopped early, as of the sponsor's last update on 8 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: See termination reason in detailed description.). Results are not available in the source record.
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?
Characterization of effect of 4-month exercise and/or Vitamin D intervention on mobility function and strength in frail elderly subjects. (time frame: Throughout trial). 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 8 Jan 2009.