Vitamin D DeficiencyNCT02485197
Muscle Metabolic Function in Older Adults With Different Vitamin D Status Before and After Exercise
A study testing 7 continuous days of aerobic training in people with Vitamin D Deficiency, run by David Travis Thomas at 1 site in United States.
Trial summary
This is a small pilot aerobic training trial designed to examine differences between normal-high and low vitamin D levels and 7-days of aerobic training on local VO2 measured by non-invasive Hybrid Diffuse Optical Spectroscopy. Read more about this study
- Who is it for?
- Ages 65 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- 7 continuous days of aerobic training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Jun 2015
- Phase
- Interventional
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65-75 years of age
Who cannot join
- Currently have or have a history of cardiovascular or pulmonary disease that would preclude the involvement in the performance of exercise.
- Uncontrolled diabetes or hypertension.
- History of neurological conditions related to spinal derangement, disk disease, peripheral neuropathies, tremor and rigidity
- History of leg/hip trauma, inflammation, infection rhabdomyolysis, or leg surgery in the past 3 months
- Have a diagnosis of osteoporosis (as determined by DXA)
- Participated in a resistance or aerobic training program in the last 3 months
Show all 9Show fewer
- Engage in more than 1 hr/week of vigorous activity
- Body mass index >29
- On hormone replacement therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study Investigating Differences in Muscle Metabolic Function in Individuals Aged 65-75 Years With Different Vitamin D Status Before and After 7-days of Aerobic Training
This is a small pilot aerobic training trial designed to examine differences between normal-high and low vitamin D levels and 7-days of aerobic training on local VO2 measured by non-invasive Hybrid Diffuse Optical Spectroscopy.
- Conditions
- Vitamin D Deficiency
- Being tested
- 7 continuous days of aerobic training
- Keywords
- Muscle Metabolic Function, Vitamin D Status, 25(OH)D, Older Adults
- 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.
7 continuous days of aerobic trainingOther
For 7 consecutive days, subjects will perform up to 45 minutes of exercise consisting of treadmill walking at a progressive intensity of about 60-65% of their maximum heart rate. This heart rate range is estimated to be below 60% VO2 max.
| Study group | Role | What they receive |
|---|---|---|
| Low 25(OH)D | Other | We will recruit individuals with low 25(OH)D (<30ng/mL). Receives: Other: 7 continuous days of aerobic training |
| High 25(OH)D | Other | We will recruit individuals with higher 25(OH)D (at least 20ng/mL units higher then that of the "low 25(OH)D group). Receives: Other: 7 continuous days of aerobic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle VO2 consumption
The objective is to examine the difference in gastrocnemius VO2 consumption in individuals that either have normal-high or low 25(OH)D and are undergoing 7-days of a treadmill training program.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startMar 2013
- Primary completionOct 2013
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies 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 N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Travis Thomas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Travis Thomas, University of Kentucky
- Investigators
- David T Thomas, PhD, Principal investigator, University of KentuckyMaja Redzic, MS, Study director, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485197
- Sponsor's protocol ID
- 12-1029-F6A
- Status last verified
- Mar 2017
- First submitted
- 25 Apr 2013
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Investigating Differences in Muscle Metabolic Function in Individuals Aged 65-75 Years With Different Vitamin D Status Before and After 7-days of Aerobic Training
- ClinicalTrials.gov ID
- NCT02485197
- Acronym / sponsor ID
- 12-1029-F6A
- Conditions
- Vitamin D Deficiency
- Keywords
- Muscle Metabolic Function, Vitamin D Status, 25(OH)D, Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- David Travis ThomasUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 30 Jun 2015 (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.
This is a small pilot aerobic training trial designed to examine differences between normal-high and low vitamin D levels and 7-days of aerobic training on local VO2 measured by non-invasive Hybrid Diffuse Optical Spectroscopy.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low 25(OH)D | Other | Other: 7 continuous days of aerobic trainingWe will recruit individuals with low 25(OH)D (<30ng/mL). |
| High 25(OH)D | Other | Other: 7 continuous days of aerobic trainingWe will recruit individuals with higher 25(OH)D (at least 20ng/mL units higher then that of the "low 25(OH)D group). |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 65-75 years of age
Key exclusion criteria (9 listed)
- Currently have or have a history of cardiovascular or pulmonary disease that would preclude the involvement in the performance of exercise.
- Uncontrolled diabetes or hypertension.
- History of neurological conditions related to spinal derangement, disk disease, peripheral neuropathies, tremor and rigidity
- History of leg/hip trauma, inflammation, infection rhabdomyolysis, or leg surgery in the past 3 months
- Have a diagnosis of osteoporosis (as determined by DXA)
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 |
|---|---|---|
| 7 continuous days of aerobic trainingFor 7 consecutive days, subjects will perform up to 45 minutes of exercise consisting of treadmill walking at a progressive intensity of about 60-65% of their maximum heart rate. This heart rate range is estimated to be below 60% VO2 max. | Other | High 25(OH)D, Low 25(OH)D |
Primary outcome
Muscle VO2 consumption
Time frame: Up to 3 months
The objective is to examine the difference in gastrocnemius VO2 consumption in individuals that either have normal-high or low 25(OH)D and are undergoing 7-days of a treadmill training program.
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 17 Mar 2017.
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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.
David T Thomas, PhD principal investigator
University of Kentucky
Maja Redzic, MS study director
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 7 continuous days of aerobic training in people with Vitamin D Deficiency, run by David Travis Thomas 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 9 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 17 Mar 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.
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?
Muscle VO2 consumption (time frame: Up to 3 months). 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 17 Mar 2017.