Physical FunctionEarly Phase 1NCT01179503
Vitamin D Supplementation and Physical Function in Older Adults
A Early Phase 1 study testing calcium and Vitamin D plus calcium in people with Physical Function and Vitamin D Insufficiency, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
A growing body of evidence suggests that vitamin D status is important in biologic processes involved in the maintenance of physical function. To advance the investigators understanding of the role of vitamin D in physical function, the investigators will conduct a feasibility pilot study to collect key information to… Read more about this study
- Who is it for?
- Ages 70 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Function, Vitamin D Insufficiency
- What is being tested?
- calcium and Vitamin D plus calcium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to May 2011
- Phase
- Early 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 70 to 89 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Short Physical Performance Battery (SPPB) score of ≥ 4 to < 10
- Vitamin D insufficient (serum 25(OH)D ≥ 10 to < 25 ng/mL)
Who cannot join
- Serious or uncontrolled chronic disease including: insulin-dependent or uncontrolled diabetes; cancer requiring treatment in past year, except non-melanoma skin cancers; past or current ischemic heart disease, uncontrolled angina, heart failure, peripheral artery disease (PAD), or stroke; chronic respiratory disease; uncontrolled endocrine/metabolic disease; neurological or hematological disease; liver or renal dysfunction; and severe musculoskeletal impairment
- Impaired cognitive function (MMSE ≤ 24)
- Dependent on a cane or walker
- Use of anti-coagulants
- Unwillingness to undergo a muscle biopsy
- Taking prescription vitamin D2 or OCT vitamin D3 supplements of > 1000 IU/d
Show all 9Show fewer
- Inability or contraindications to consume daily vitamin D and calcium supplements
- Weight loss of ≥ 5% or more in the past 6 months
- Involved in any other intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: Vitamin D Supplementation, Skeletal Muscle Gene Expression, and Physical Performance in Older Adults
A growing body of evidence suggests that vitamin D status is important in biologic processes involved in the maintenance of physical function. To advance the investigators understanding of the role of vitamin D in physical function, the investigators will conduct a feasibility pilot study to collect key information to help design a full-scale randomized trial to determine whether vitamin D supplementation will delay declines in physical function. The primary goals of the pilot study are to determine cost-effective strategies for identifying persons at high risk for functional decline with insufficient vitamin D levels, determine the serum vitamin D response to a vitamin D supplementation regimen designed to attain sufficient vitamin D levels, and provide preliminary data of key functional measures (balance, physical performance and muscle power) for the future larger study design. A secondary goal is to begin to examine potential mechanisms by which vitamin D supplementation may enhance physical performance by exploring the effects of vitamin D supplementation on changes in skeletal muscle gene expression.
Read the detailed description
A growing body of evidence suggests that vitamin D status is important in biologic processes involved in the maintenance of physical function. However, whether remediation of vitamin D insufficiency will improve physical function and the potential mechanisms involved are unclear. Previous vitamin D supplementation trials have produced mixed results with respect to physical function; however, most trials did not specifically recruit individuals who were vitamin D insufficient nor is the potential mechanism of action understood well enough to appropriately select those individuals most likely to benefit. To advance our understanding of the role of vitamin D in physical function, the investigators will conduct a feasibility pilot study to collect key information to help design a full-scale randomized trial to determine whether vitamin D supplementation will delay declines in physical function. The primary goals of the pilot study are to determine cost-effective strategies for identifying persons at high risk for functional decline with insufficient vitamin D levels, determine the serum vitamin D response to a vitamin D supplementation regimen designed to attain sufficient vitamin D levels, and provide preliminary data of key functional measures (balance, short physical performance battery (SBBP) and muscle power) for the future larger study design. A secondary goal is to begin to examine potential mechanisms by which vitamin D supplementation may enhance physical performance and muscle contractility by exploring the effects of vitamin D supplementation on changes in skeletal muscle gene expression using microarrays.
- Conditions
- Physical Function, Vitamin D Insufficiency
- Being tested
- calcium, Vitamin D plus calcium
- Keywords
- vitamin D, physical performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calciumDietary supplement
600 mg calcium carbonate twice daily (total of 1200 mg/day) for 4 months
Vitamin D plus calciumDietary supplement
1000 IU of vitamin D3 twice daily (for a total of 2000 IU/day) plus 600 mg calcium carbonate twice daily (for a total of 1200 mg/day)
| Study group | Role | What they receive |
|---|---|---|
| Calcium only | Active comparator | 1200 mg Calcium per day Receives: Dietary Supplement: calcium |
| Vitamin D plus calcium | Experimental | 2000 IU vitamin D plus 1200 mg calcium per day Receives: Dietary Supplement: Vitamin D plus calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical performance
Change in the expanded Short Physical Performance Battery (SPPB) score (composite score including the following: timed 4m walk; time to stand from a chair 5 times without the use of arms; and time to hold side-by-side, semi-tandem, tandem, and one legged stands for the testing of balance)
Measured: 4 months
Secondary outcomes (5)
Skeletal muscle gene expression
Muscle will be obtained from the vastus lateralis using the percutaneous needle biopsy technique. Five µg of RNA will be supplied for each experimental condition to be analyzed. The WFUHS MicroArray Core Facility further purifies the provided RNA over an RNAeasy column and performs all subsequent steps of the GeneChip protocol (cDNA generation, generation of biotinylated cRNA, chip hybridization, and generation of .CEL files).
Measured: 4 months
Change in expanded SPPB balance task time
Change in expanded SPPB balance task time (time to hold side-by-side, semi-tandem, tandem, and one legged stands; max of 30 sec)
Measured: 4 months
Change in narrow 4m walk test of balance time
Change in time to complete narrow 4m walk test of balance (usual pace over 4m while staying between lines of colored tape placed 20cm apart)
Measured: 4 months
Change in 400m walk test time
Change in 400m walk test time (usual pace)
Measured: 4 months
Change in knee extensor power
Change in knee extensor power measured by the Nottingham Power Rig
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2010 (estimated)
- Study startJan 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical FunctionStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Denise K Houston, PhD, Study director, Wake Forest UniversityStephen B Kritchevsky, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01179503
- Sponsor's protocol ID
- IRB00011371
- Other IDs
- R01AG029364-03S1
- Status last verified
- Aug 2018
- First submitted
- 10 Aug 2010
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Supplementation, Skeletal Muscle Gene Expression, and Physical Performance in Older Adults
- ClinicalTrials.gov ID
- NCT01179503
- Acronym / sponsor ID
- IRB00011371
- Conditions
- Physical Function, Vitamin D Insufficiency
- Keywords
- vitamin D, physical performance
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Jan 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 11 Aug 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.
A growing body of evidence suggests that vitamin D status is important in biologic processes involved in the maintenance of physical function. To advance the investigators understanding of the role of vitamin D in physical function, the investigators will conduct a feasibility pilot study to collect key information to help design a full-scale randomized trial to determine whether vitamin D supplementation will delay declines in physical function. The primary goals of the pilot study are to determine cost-effective strategies for identifying persons at high risk for functional decline with insufficient vitamin D levels, determine the serum vitamin D response to a vitamin D supplementation regimen designed to attain sufficient vitamin D levels, and provide preliminary data of key functional measures (balance, physical performance and muscle power) for the future larger study design. A secondary goal is to begin to examine potential mechanisms by which vitamin D supplementation may enhance physical performance by exploring the effects of vitamin D supplementation on changes in skeletal muscle gene expression.
Detailed description
A growing body of evidence suggests that vitamin D status is important in biologic processes involved in the maintenance of physical function. However, whether remediation of vitamin D insufficiency will improve physical function and the potential mechanisms involved are unclear. Previous vitamin D supplementation trials have produced mixed results with respect to physical function; however, most trials did not specifically recruit individuals who were vitamin D insufficient nor is the potential mechanism of action understood well enough to appropriately select those individuals most likely to benefit. To advance our understanding of the role of vitamin D in physical function, the investigators will conduct a feasibility pilot study to collect key information to help design a full-scale randomized trial to determine whether vitamin D supplementation will delay declines in physical function. The primary goals of the pilot study are to determine cost-effective strategies for identifying persons at high risk for functional decline with insufficient vitamin D levels, determine the serum vitamin D response to a vitamin D supplementation regimen designed to attain sufficient vitamin D levels, and provide preliminary data of key functional measures (balance, short physical performance battery (SBBP) and muscle power) for the future larger study design. A secondary goal is to begin to examine potential mechanisms by which vitamin D supplementation may enhance physical performance and muscle contractility by exploring the effects of vitamin D supplementation on changes in skeletal muscle gene expression using microarrays.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcium only | Active comparator | Dietary Supplement: calcium1200 mg Calcium per day |
| Vitamin D plus calcium | Experimental | Dietary Supplement: Vitamin D plus calcium2000 IU vitamin D plus 1200 mg calcium per day |
Who may qualify
- Ages
- 70 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Short Physical Performance Battery (SPPB) score of ≥ 4 to < 10
- Vitamin D insufficient (serum 25(OH)D ≥ 10 to < 25 ng/mL)
Key exclusion criteria (9 listed)
- Serious or uncontrolled chronic disease including: insulin-dependent or uncontrolled diabetes; cancer requiring treatment in past year, except non-melanoma skin cancers; past or current ischemic heart disease, uncontrolled angina, heart failure, peripheral artery disease (PAD), or stroke; chronic respiratory disease; uncontrolled endocrine/metabolic disease; neurological or hematological disease; liver or renal dysfunction; and severe musculoskeletal impairment
- Impaired cognitive function (MMSE ≤ 24)
- Dependent on a cane or walker
- Use of anti-coagulants
- Unwillingness to undergo a muscle biopsy
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 |
|---|---|---|
| calcium600 mg calcium carbonate twice daily (total of 1200 mg/day) for 4 months | Dietary supplement | Calcium only |
| Vitamin D plus calcium1000 IU of vitamin D3 twice daily (for a total of 2000 IU/day) plus 600 mg calcium carbonate twice daily (for a total of 1200 mg/day) | Dietary supplement | Vitamin D plus calcium |
Primary outcome
Change in Physical performance
Time frame: 4 months
Change in the expanded Short Physical Performance Battery (SPPB) score (composite score including the following: timed 4m walk; time to stand from a chair 5 times without the use of arms; and time to hold side-by-side, semi-tandem, tandem, and one legged stands for the testing of balance)
5 secondary outcomes
Skeletal muscle gene expression
Time frame: 4 months
Change in expanded SPPB balance task time
Time frame: 4 months
Change in narrow 4m walk test of balance time
Time frame: 4 months
Change in 400m walk test time
Time frame: 4 months
Change in knee extensor power
Time frame: 4 months
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 Aug 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.
Denise K Houston, PhD study director
Wake Forest University
Stephen B Kritchevsky, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing calcium and Vitamin D plus calcium in people with Physical Function and Vitamin D Insufficiency, run by Wake Forest University Health Sciences 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 2 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 Aug 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Change in Physical performance (time frame: 4 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 Aug 2018.