Neuromuscular FunctionEVIDENCENCT02015611
Vitamin D Supplementation and Muscle Function in Older Adults
A study testing Vitamin D in people with Neuromuscular Function, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this study is to see if vitamin D supplementation improves muscle function in older adults. Read more about this study
- Who is it for?
- Ages 65 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Function
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to 26 Sep 2018
- Phase
- Interventional
- 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 89 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age ≥65 to <90 years
- SPPB <=10
- Initial serum 25(OH)D concentration of 18 to <30 ng/mL
- Not dependent on a walker
- Able to provide own transportation to study visits
- Not involved in another intervention study
- Willing to provide informed consent and adhere to the protocol
Who cannot join
- Serious or uncontrolled chronic disease including: insulin-dependent diabetes; cancer requiring treatment in past year, except non-melanoma skin cancers; acute coronary event (within the last 6 months), uncontrolled angina, heart failure (stage 3-4), PAD, or stroke (within the last 6 months); uncontrolled hypertension (BP>200/110 mmHg); chronic respiratory disease requiring the use of oxygen; uncontrolled endocrine/metabolic disease; neurological (e.g., Parkinson's disease) or hematological disease; liver or renal dysfunction (eGFR <45 mL/min/1.73m2); and musculoskeletal impairments severe enough to preclude functional testing
- Evidence of impaired cognitive function (MoCA <18)
- Taking prescription vitamin D2 or taking >1000 IU/day of vitamin D3 (from all sources); taking an oral corticosteroid (i.e., prednisone at 7.5mg/d for 3 mos or equivalent); taking hormone replacement therapy
- Inability or contraindications to consume daily vitamin D supplements (e.g., hypercalcemia, sarcoidosis, history of kidney stones in last 5 years)
- Knee or hip surgery within the last 6 months or planned knee or hip surgery within the next year
- Unwillingness to undergo a muscle biopsy or use of anti-coagulants
Show all 9Show fewer
- Unintentional weight loss of ≥5% or more in the past 3 months
- BMI >40 kg/m2
- If the PI feels the participant is unlikely to follow the protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Trial of Vitamin D Supplementation and Neuromuscular Function in Older Adults
The purpose of this study is to see if vitamin D supplementation improves muscle function in older adults.
Read the detailed description
This study is a 12-month, double-blind randomized placebo controlled trial in older (65-89 yrs) men and women with initial 25(OH)D concentrations of 18-<30 ng/mL to determine the effect of increasing 25(OH)D concentrations to ≥30 ng/mL through vitamin D3 supplementation on 1) change in neuromuscular functions that are established risk-factors for falls in older adults; and 2) changes in the underlying physiological mechanisms over 4 months in a subset of randomly selected participants. Participants will be randomized to 2000 IU/d of vitamin D3 or placebo. Lower extremity muscle strength and power, physical performance, and postural sway will be assessed at baseline, 4 months and 12 months and falls assessed monthly. Muscle biopsies of the vastus lateralis will be taken at baseline and 4 months to assess muscle fiber type, contractility, and denervation, and number and differentiation stage of satellite cells.
- Conditions
- Neuromuscular Function
- Being tested
- Vitamin D, Placebo
- Keywords
- Vitamin D, Muscle power, Muscle fiber, Falls, Aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
2,000 IU/ day of Vitamin D3
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Matched bottle/pill placebo Receives: Dietary Supplement: Placebo |
| Vitamin D | Experimental | 2,000 IU Vitamin D3 per day Receives: Dietary Supplement: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lower Extremity Muscle Power Over 12 Months
Lower extremity muscle power will be measured at baseline, 4- and 12-month follow-up using the Nottingham Power Rig. Participants sit in a chair and unilaterally depress a foot lever attached to a flywheel as hard and as fast as they can. Power output, derived from the acceleration of the flywheel from 5 trials on each leg at maximal effort, will be recorded in Watts. Maximum leg power at baseline (from either the right or left leg) and the maximum power from the same leg at 4- and 12-month follow-up will be used in all analyses. Leg power (Watts) will be standardized to total body mass (in Kg).
Measured: change from baseline at 12 month follow-up reported
Change in Percentage of Type II (Fast-twitch) Muscle Fibers Over 4 Months
This will be examined in muscle biopsies collected at baseline and 4-month follow-up using the ATPase, pH 9.4 technique, combined with laminin immunostaining in 10 micrometer muscle sections and the number of type I and type II fiber subtypes quantified. The percentage of type II fibers is calculated by dividing the number of type II fibers by the sum of type I and type II fibers combined.
Measured: over 4 months of follow-up
Secondary outcomes (8)
Change in Lower Extremity Muscle Strength Over 12 Months
Lower extremity muscle strength will be measured using an isokinetic dynamometer (Biodex) at one speed (60°/sec) with the participant sitting and the hips and knee flexed at 90°. Participants extend the knee and push as hard as possible against the resistance pad. Strength is expressed as peak torque in Newton-meters (Nm). The maximum knee extensor strength of the 4 repetitions from trial 2 for the dominant leg will be will be used in analyses unless unable to test the dominant leg (i.e., knee replacement) in which case the non-dominant leg will be used; the maximum knee extensor strength from the same leg will be used at 4- and 12-month follow-up for all analyses.
Measured: change from baseline at 12 month follow-up reported
Change in the Short Physical Performance Battery (SPPB) Score Over 12 Months
The short physical performance battery consists of standing balance (side-by-side, semi- and full-tandem stands for 10 seconds), a 4-m walk to assess usual gait speed, and 5 repeated chair stands at baseline, 4-months and 12-months. Each of the three performance measures is assigned a score ranging from 0 (inability to perform the task) to 4 (the highest level of performance) and summed to create an SPPB score ranging from 0 to 12 (best).
Measured: change from baseline at 12 month follow-up reported
Change in the Expanded Physical Performance Battery Score Over 12 Months
The expanded physical performance battery consists of standing balance (semi- and full-tandem stands and a single leg stand for 30 seconds), a 4-m walk to assess usual gait speed, a narrow 4-m walk test of balance (walking at usual pace within lines of tape spaced 20 cm apart), and 5 repeated chair stands at baseline, 4-months, and 12-months. Scores range from 0 to 4 with higher scores indicative of better physical performance.
Measured: change from baseline at 12 month follow-up reported
Change in Timed Up and Go (TUG) Over 12 Months
The timed up and go will be measured by how long it takes (sec) to stand up from a chair, walk 3 m, turn around, walk back to the chair, and sit down at baseline, 4-months, and 12-months. Longer times to complete the TUG are indicative of greater fall risk.
Measured: change from baseline at 12 month follow-up reported
Change in Average Sway Velocity Over 12 Months
Postural sway during quiet stance will be assessed from Center-of-Pressure (COP) trajectory data collected at 100 Hz using an Advanced Mechanical Technology Incorporated (AMTI) AccuSway biomechanics force platform at baseline, 4-months, and 12-months. Participants stand on the force platform barefoot in an upright stance with arms relaxed comfortably at their sides, eyes open, feet abducted 10 degrees, and heels separated medio-laterally by 6 cm. COP data is collected in a series of 10 30-sec trials standing on the force plate. Average sway velocity is measured in cm/sec. A higher number indicates more postural sway.
Measured: change from baseline at 12 month follow-up reported
Change in 95% Confidence Ellipse Area Over 12 Months
Postural sway during quiet stance will be assessed from Center-of-Pressure (COP) trajectory data collected at 100 Hz using an Advanced Mechanical Technology Incorporated (AMTI) AccuSway biomechanics force platform at baseline, 4-months, and 12-month. Participants stand on the force platform barefoot in an upright stance with arms relaxed comfortably at their sides, eyes open, feet abducted 10 degrees, and heels separated medio-laterally by 6 cm. COP data is collected in a series of 10 30-sec trials standing on the force plate. 95% confidence ellipse area is measured in cm squared. A higher number indicates more postural sway.
Measured: change from baseline at 12 month follow-up reported
Change in Maximum Anteroposterior (AP) Displacement Over 12 Months
Postural sway during quiet stance will be assessed from Center-of-Pressure (COP) trajectory data collected at 100 Hz using an Advanced Mechanical Technology Incorporated (AMTI) AccuSway biomechanics force platform at baseline, 4-months, and 12-months. Participants stand on the force platform barefoot in an upright stance with arms relaxed comfortably at their sides, eyes open, feet abducted 10 degrees, and heels separated medio-laterally by 6 cm. COP data is collected in a series of 10 30-sec trials standing on the force plate. Anteroposterior (AP) displacement is measured in cm. A higher number indicates more postural sway.
Measured: change from baseline at 12 month follow-up reported
Change in Maximum Mediolateral (ML) Displacement Over 12 Months
Postural sway during quiet stance will be assessed from Center-of-Pressure (COP) trajectory data collected at 100 Hz using an Advanced Mechanical Technology Incorporated (AMTI) AccuSway biomechanics force platform at baseline, 4-months, and 12-months. Participants stand on the force platform barefoot in an upright stance with arms relaxed comfortably at their sides, eyes open, feet abducted 10 degrees, and heels separated medio-laterally by 6 cm. COP data is collected in a series of 10 30-sec trials standing on the force plate. Mediolateral (ML) displacement is measured in cm. A higher number indicates more postural sway.
Measured: change from baseline at 12 month follow-up reported
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startDec 2013
- Primary completion26 Sep 2018
- Study completion26 Sep 2018
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 (1)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular FunctionStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Office of Dietary Supplements (ODS)
- Responsible party
- Sponsor
- Investigators
- Denise K Houston, PhD, RD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02015611
- Sponsor's protocol ID
- IRB00022395
- Other IDs
- R01AG042411
- Acronym
- EVIDENCE
- Status last verified
- Sep 2022
- First submitted
- 9 Dec 2013
- Last updated
- 15 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Houston DK, Marsh AP, Neiberg RH, Demons JL, Campos CL, Kritchevsky SB, Delbono O, Tooze JA. Vitamin D Supplementation and Muscle Power, Strength and Physical Performance in Older Adults: A Randomized Controlled Trial. Am J Clin Nutr. 2023 Jun;117(6):1086-1095. doi: 10.1016/j.ajcnut.2023.04.021. Epub 2023 Apr 19.
PubMed 37084814
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Vitamin D Supplementation and Neuromuscular Function in Older Adults
- ClinicalTrials.gov ID
- NCT02015611
- Acronym / sponsor ID
- EVIDENCE / IRB00022395
- Conditions
- Neuromuscular Function
- Keywords
- Vitamin D, Muscle power, Muscle fiber, Falls, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Office of Dietary Supplements (ODS)
- Study start
- Dec 2013 (actual)
- Primary completion
- 26 Sep 2018 (actual)
- Study completion
- 26 Sep 2018 (actual)
- First posted
- 19 Dec 2013 (estimated)
- Results
- Posted 15 Nov 2022
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 see if vitamin D supplementation improves muscle function in older adults.
Detailed description
This study is a 12-month, double-blind randomized placebo controlled trial in older (65-89 yrs) men and women with initial 25(OH)D concentrations of 18-<30 ng/mL to determine the effect of increasing 25(OH)D concentrations to ≥30 ng/mL through vitamin D3 supplementation on 1) change in neuromuscular functions that are established risk-factors for falls in older adults; and 2) changes in the underlying physiological mechanisms over 4 months in a subset of randomly selected participants. Participants will be randomized to 2000 IU/d of vitamin D3 or placebo. Lower extremity muscle strength and power, physical performance, and postural sway will be assessed at baseline, 4 months and 12 months and falls assessed monthly. Muscle biopsies of the vastus lateralis will be taken at baseline and 4 months to assess muscle fiber type, contractility, and denervation, and number and differentiation stage of satellite cells.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMatched bottle/pill placebo |
| Vitamin D | Experimental | Dietary Supplement: Vitamin D2,000 IU Vitamin D3 per day |
Who may qualify
- Ages
- 65 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Age ≥65 to <90 years
- SPPB <=10
- Initial serum 25(OH)D concentration of 18 to <30 ng/mL
- Not dependent on a walker
- Able to provide own transportation to study visits
Key exclusion criteria (9 listed)
- Serious or uncontrolled chronic disease including: insulin-dependent diabetes; cancer requiring treatment in past year, except non-melanoma skin cancers; acute coronary event (within the last 6 months), uncontrolled angina, heart failure (stage 3-4), PAD, or stroke (within the last 6 months); uncontrolled hypertension (BP>200/110 mmHg); chronic respiratory disease requiring the use of oxygen; uncontrolled endocrine/metabolic disease; neurological (e.g., Parkinson's disease) or hematological disease; liver or renal dysfunction (eGFR <45 mL/min/1.73m2); and musculoskeletal impairments severe enough to preclude functional testing
- Evidence of impaired cognitive function (MoCA <18)
- Taking prescription vitamin D2 or taking >1000 IU/day of vitamin D3 (from all sources); taking an oral corticosteroid (i.e., prednisone at 7.5mg/d for 3 mos or equivalent); taking hormone replacement therapy
- Inability or contraindications to consume daily vitamin D supplements (e.g., hypercalcemia, sarcoidosis, history of kidney stones in last 5 years)
- Knee or hip surgery within the last 6 months or planned knee or hip surgery within the next year
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 D2,000 IU/ day of Vitamin D3 | Dietary supplement | Vitamin D |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
Change in Lower Extremity Muscle Power Over 12 Months
Time frame: change from baseline at 12 month follow-up reported
Lower extremity muscle power will be measured at baseline, 4- and 12-month follow-up using the Nottingham Power Rig. Participants sit in a chair and unilaterally depress a foot lever attached to a flywheel as hard and as fast as they can. Power output, derived from the acceleration of the flywheel from 5 trials on each leg at maximal effort, will be recorded in Watts. Maximum leg power at baseline (from either the right or left leg) and the maximum power from the same leg at 4- and 12-month follow-up will be used in all analyses. Leg power (Watts) will be standardized to total body mass (in Kg).
Change in Percentage of Type II (Fast-twitch) Muscle Fibers Over 4 Months
Time frame: over 4 months of follow-up
This will be examined in muscle biopsies collected at baseline and 4-month follow-up using the ATPase, pH 9.4 technique, combined with laminin immunostaining in 10 micrometer muscle sections and the number of type I and type II fiber subtypes quantified. The percentage of type II fibers is calculated by dividing the number of type II fibers by the sum of type I and type II fibers combined.
8 secondary outcomes
Change in Lower Extremity Muscle Strength Over 12 Months
Time frame: change from baseline at 12 month follow-up reported
Change in the Short Physical Performance Battery (SPPB) Score Over 12 Months
Time frame: change from baseline at 12 month follow-up reported
Change in the Expanded Physical Performance Battery Score Over 12 Months
Time frame: change from baseline at 12 month follow-up reported
Change in Timed Up and Go (TUG) Over 12 Months
Time frame: change from baseline at 12 month follow-up reported
Change in Average Sway Velocity Over 12 Months
Time frame: change from baseline at 12 month follow-up reported
Change in 95% Confidence Ellipse Area Over 12 Months
Time frame: change from baseline at 12 month follow-up reported
Change in Maximum Anteroposterior (AP) Displacement Over 12 Months
Time frame: change from baseline at 12 month follow-up reported
Change in Maximum Mediolateral (ML) Displacement Over 12 Months
Time frame: change from baseline at 12 month follow-up reported
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37084814Houston DK, Marsh AP, Neiberg RH, Demons JL, Campos CL, Kritchevsky SB, Delbono O, Tooze JA. Vitamin D Supplementation and Muscle Power, Strength and Physical Performance in Older Adults: A Randomized Controlled Trial. Am J Clin Nutr. 2023 Jun;117(6):1086-1095. doi: 10.1016/j.ajcnut.2023.04.021. Epub 2023 Apr 19.
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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, RD 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 study testing Vitamin D in people with Neuromuscular Function, 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 7 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 15 Nov 2022. 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. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Nov 2022). 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?
Change in Lower Extremity Muscle Power Over 12 Months (time frame: change from baseline at 12 month follow-up reported). The study lists 2 primary outcomes in all. 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 NCT02015611, which also lists 1 linked publication.
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 Nov 2022.