HealthyNCT02221596
Vitamin D and Muscle Metabolic Function
A study testing vitamin D and aerobic training in people with Healthy, run by David Travis Thomas at 1 site in United States.
Trial summary
The purpose of this study is to identify the magnitude of muscle lipid redistribution and muscle oxygen use in individuals 60 years old or older following combined treatment of vitamin D repletion and aerobic training compared to vitamin D repletion alone, aerobic training alone, or no treatment. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- vitamin D and aerobic training
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to 1 Mar 2018
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 60 and older
- BMI: 18.5-29
- Communicates fluently in English
Who cannot join
- Metal implant not suitable for MRI
- Any form of hormone replacement therapy
- Engage in more than 1 hr/week of vigorous activity
- Participated in a high-intensity resistance or aerobic training program in the last 3 months
- Lower extremity injury or surgery in the past 3 months
- Foot sores or bone conditions severely limiting ability to move or perform exercise or joint pain made worse by mild exercise
Show all 14Show fewer
- Diabetes, inflammatory bowel disease, renal disease or uncontrolled hypertension.
- Currently have or had a history of cardiovascular or pulmonary disease that would preclude the involvement in the performance of exercise
- History of myopathy (including congenital myopathies)
- History of neurological conditions related to spinal derangement, disk disease, peripheral neuropathies, tremor and rigidity
- Past medical history of hyperparathyroidism, kidney stones or rhabdomyolysis
- Currently receiving treatment for vitamin D deficiency
- Vitamin D level >30ng/mL
- Currently smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin D Contribution to Muscle Metabolic Function in Aged Adults
The purpose of this study is to identify the magnitude of muscle lipid redistribution and muscle oxygen use in individuals 60 years old or older following combined treatment of vitamin D repletion and aerobic training compared to vitamin D repletion alone, aerobic training alone, or no treatment.
Read the detailed description
The investigators plan to recruit approximately 56 aged individuals with vitamin D insufficiency for a 13 week trial. All subjects will be 60 years of age or older. Participants will be randomized to one of four groups: vitamin D (50,000IU/wk) + aerobic training (7 days during the 13th week); vitamin D (50,000IU/wk) + normal daily activity during the 13th week; placebo + aerobic training (7 days during the 13th week); or placebo + normal daily activity during the 13th week.
Following screening and informed consent process a physical activity questionnaire will be administered. A blood draw will then be conducted at baseline, midpoint and endpoint. Collected blood for the purposes of this study will assess vitamin D status (25(OH)D), parathyroid hormone, ionized calcium, insulin, and a comprehensive metabolic panel. At baseline and endpoint muscle lipid will be assessed using Magnetic Resonance Spectroscopy and muscle oxygen consumption will be determined using a novel hybrid diffuse optical instrument consisting of a near-infrared spectroscopy and a diffuse correlation spectroscopy. In addition, at each study time point 3 dietary recalls will be completed and physical activity will be measured using an accelerometer.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin DDietary supplement
50,000IU/wk of vitamin D3
aerobic trainingOther
7 days of treadmill training during the 13th week of study
| Study group | Role | What they receive |
|---|---|---|
| vitamin D + aerobic training | Experimental | vitamin D capsules every weekday (10,000IU/day) and exercise Receives: Dietary Supplement: vitamin D; Other: aerobic training |
| vitamin D + no aerobic training | Active comparator | vitamin D capsules every weekday (10,000IU/day) and no exercise Receives: Dietary Supplement: vitamin D |
| placebo + aerobic training | Active comparator | placebo capsule every weekday and exercise Receives: Other: aerobic training |
| placebo + no aerobic training | No intervention | placebo capsule every weekday and no exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood measure
vitamin D
Measured: Change from Baseline in vitamin D at 13 weeks
Secondary outcomes (2)
muscle lipid
Intramyocellular lipid and extramyocellular lipid will be assessed using magnetic resonance spectroscopy and fat segmentation.
Measured: baseline and 13 weeks after baseline
muscle oxygen consumption
Local muscle tissue oxidative capacity will be measured using a novel hybrid diffuse optical instrument consisting of a near-infrared spectroscopy (NIRS) and a diffuse correlation spectroscopy (DCS)
Measured: baseline and 13 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startSep 2014
- Primary completion28 Feb 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 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
- D. Travis Thomas, Ph.D., RD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02221596
- Sponsor's protocol ID
- 1R21AG046762-01A1
- Status last verified
- Mar 2018
- First submitted
- 14 Aug 2014
- Last updated
- 15 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Contribution to Muscle Metabolic Function in Aged Adults
- ClinicalTrials.gov ID
- NCT02221596
- Acronym / sponsor ID
- 1R21AG046762-01A1
- Conditions
- Healthy
- Keywords
- Vitamin D, 25(OH)D, Aerobic training, Near-infrared spectroscopy, Diffuse correlation spectroscopy, MRS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- David Travis ThomasUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 20 Aug 2014 (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 purpose of this study is to identify the magnitude of muscle lipid redistribution and muscle oxygen use in individuals 60 years old or older following combined treatment of vitamin D repletion and aerobic training compared to vitamin D repletion alone, aerobic training alone, or no treatment.
Detailed description
The investigators plan to recruit approximately 56 aged individuals with vitamin D insufficiency for a 13 week trial. All subjects will be 60 years of age or older. Participants will be randomized to one of four groups: vitamin D (50,000IU/wk) + aerobic training (7 days during the 13th week); vitamin D (50,000IU/wk) + normal daily activity during the 13th week; placebo + aerobic training (7 days during the 13th week); or placebo + normal daily activity during the 13th week.
Following screening and informed consent process a physical activity questionnaire will be administered. A blood draw will then be conducted at baseline, midpoint and endpoint. Collected blood for the purposes of this study will assess vitamin D status (25(OH)D), parathyroid hormone, ionized calcium, insulin, and a comprehensive metabolic panel. At baseline and endpoint muscle lipid will be assessed using Magnetic Resonance Spectroscopy and muscle oxygen consumption will be determined using a novel hybrid diffuse optical instrument consisting of a near-infrared spectroscopy and a diffuse correlation spectroscopy. In addition, at each study time point 3 dietary recalls will be completed and physical activity will be measured using an accelerometer.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| vitamin D + aerobic training | Experimental | Dietary Supplement: vitamin D, Other: aerobic trainingvitamin D capsules every weekday (10,000IU/day) and exercise |
| vitamin D + no aerobic training | Active comparator | Dietary Supplement: vitamin Dvitamin D capsules every weekday (10,000IU/day) and no exercise |
| placebo + aerobic training | Active comparator | Other: aerobic trainingplacebo capsule every weekday and exercise |
| placebo + no aerobic training | No intervention | –placebo capsule every weekday and no exercise |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 60 and older
- BMI: 18.5-29
- Communicates fluently in English
Key exclusion criteria (14 listed)
- Metal implant not suitable for MRI
- Any form of hormone replacement therapy
- Engage in more than 1 hr/week of vigorous activity
- Participated in a high-intensity resistance or aerobic training program in the last 3 months
- Lower extremity injury or surgery in the past 3 months
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 D50,000IU/wk of vitamin D3 | Dietary supplement | vitamin D + aerobic training, vitamin D + no aerobic training |
| aerobic training7 days of treadmill training during the 13th week of study | Other | placebo + aerobic training, vitamin D + aerobic training |
Primary outcome
blood measure
Time frame: Change from Baseline in vitamin D at 13 weeks
vitamin D
2 secondary outcomes
muscle lipid
Time frame: baseline and 13 weeks after baseline
muscle oxygen consumption
Time frame: baseline and 13 weeks after baseline
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 15 Mar 2018.
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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.
D. Travis Thomas, Ph.D., RD principal investigator
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 vitamin D and aerobic training in people with Healthy, 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 3 inclusion and 14 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 15 Mar 2018. 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?
blood measure (time frame: Change from Baseline in vitamin D at 13 weeks). 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 15 Mar 2018.