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SarcopeniaEXVITDNCT02467153

Vitamin D and Resistance Exercise Training; Effects on Musculoskeletal Health in Frail Older Men and Women

A study testing RET and Vitamin D3 in people with Sarcopenia and Muscle Atrophy, run by University of Birmingham at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to determine whether vitamin D3 supplementation is any more effective in improving musculoskeletal function when combined with exercise training compared with exercise training alone. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Sarcopenia, Muscle Atrophy, Osteoporosis
What is being tested?
RET and Vitamin D3
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
19 participants
Where
1 siteUnited Kingdom
Study dates
1 Jan 2017to 16 Dec 2019
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Aged 65 years or over
  • Ambulatory (with or without walking aids)

Who cannot join

  • History of myocardial infarction within previous 2 years
  • Cardiac illness: moderate/ severe aortic stenosis, acute pericarditis, acute myocarditis, aneurysm, severe angina, clinically significant valvular disease, uncontrolled dysrhythmia, claudication within the previous 10 years; thrombophlebitis or pulmonary embolus within the previous 2 years
  • History of cerebrovascular disease (CVA or TIA) within the previous 2 years
  • Acute febrile illness within the previous 3 months
  • Severe airflow obstruction; uncontrolled metabolic disease (e.g., thyroid disease or cancer)
  • Significant emotional distress, psychotic illness or depression within the previous 2 years
Show all 17Show fewer
  • Lower limb fracture sustained within the previous 2 years/ upper limb fracture within the previous 6 months
  • Non-arthroscopic lower limb joint surgery within the previous 2 years
  • Any reason for loss of mobility for greater than 1 week in the previous 2 months or greater than 2 weeks in the previous 6 months
  • Resting systolic pressure >200 millimeters of mercury (mmHg) or resting diastolic pressure >100 mmHg
  • Poorly controlled atrial fibrillation; poor (chronic) pain control
  • Moderate/severe cognitive impairment (mini mental state examination (MMSE) score <23)
  • Vitamin D deficient (serum 25(OH)D3 <30nmol/l); current antiresorptive or anabolic treatment for osteoporosis
  • Treatment with bisphosphonates for osteoporosis in the past two years
  • Current supplement use of vitamin D (>400 IU/day) or calcium (>500 mg/day including use of over the counter preparations)
  • Current use of glucocorticoids; known primary hyperparathyroidism; hypercalcaemia (albumin-adjusted serum calcium >2.60 mmol/l)
  • Renal impairment (Stage 4 or 5)

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • University of Birmingham

    Birmingham, B15 2TT

Other trials in United Kingdom

About this study

Official title: Influence of Combined Vitamin D Supplementation and Resistance Exercise Training on Musculoskeletal Health in Frail Older Men and Women (EXVITD)

This study aims to determine whether vitamin D3 supplementation is any more effective in improving musculoskeletal function when combined with exercise training compared with exercise training alone.

Read the detailed description

We are an ageing population with life expectancy currently increasing at 2 years per decade. Crucially, healthy life expectancy is not keeping pace and older adults are now spending longer in poor health.

Sarcopenia represents a major, serious and increasing public health problem. While the causes of sarcopenia are still unclear, vitamin D deficiency, which is widespread among older adults (reaching 90% in residential care), is associated with an increased risk of falls and fractures as well as skeletal muscle weakness. While it is known that vitamin D is essential for bone health, relatively little is known about the direct effects of vitamin D3 supplementation on human muscle mass and function in humans.

Physical activity (resistance exercise training (RET) in particular) is the most potent stimulus for skeletal muscle hypertrophy in both young and older adults. The researchers and others have shown that even in very old adults (>75 years) and frail patient groups, RET improves muscle strength and functional outcomes although the hypertrophic ability of older muscle is blunted compared with younger adults. Therefore in order to help older adults maintain good musculoskeletal health, interventions to optimise responsiveness to physical activity are likely to be most effective if they are multimodal, and include resistance exercise. One example of this is to combine resistance exercise training with vitamin D supplementation.

The aim of the EXVITD study is to determine whether vitamin D3 supplementation is any more effective in improving musculoskeletal function when combined with exercise training compared with exercise training alone.

The researchers aim to recruit 127 men and women aged 65 years or over who are ambulatory (with or without walking aids) and live in supported housing settings. Recruitment will be via local housing trusts/seniors groups.

Participants will be randomised to RET (x3 per week) + 800 International Units (IU) vitamin D3 (daily) supplement or RET + placebo for six months. Participants will be stratified on the basis of vitamin D status, physical activity (measured directly pre-randomisation using accelerometry), and sex.

Tests will include, but are not limited to, lower limb extensor power (LLEP) output, body composition, Short Physical Performance Battery (SPPB), Timed-up-and-go (TUG),power required to rise from a chair, physical activity, perception of musculoskeletal comfort/pain, falls as events, quality of life and venepuncture for biochemical markers.

Being tested
RET, Placebo, Vitamin D3
Keywords
Sarcopenia, Older adult, Vitamin D, Physical activity, Muscle atrophy, Muscle strength, Physical function, Frailty, Osteoporosis
Medical subject headings
Sarcopenia, Muscular Atrophy, Osteoporosis, Motor Activity, Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RETOther

    RET: A supervised group exercise programme with a maximum of n=10-12 participants per group to be attended 3 times per week for 6 months.

    The RET programme includes elements of current established programmes for falls prevention/ core stability (i.e., OTAGO, PEPPI) and will tailored to a range of abilities within the target group.

    Vitamin D3 supplementation: vitamin D3 given orally as tablets at a dosage of 800 IU/day for 6 months.

  • PlaceboDietary supplement

    Placebo given orally as tablets; 1 tablet per day for 6 months.

  • Vitamin D3Dietary supplement

    Placebo given orally as tablets; 800 IU as 1 tablet per day for 6 months.

Study groups in NCT02467153
Study groupRoleWhat they receive
RET + vitamin D3ExperimentalResistance Exercise Training (RET) + vitamin D3 given orally as tablets at a dosage of 800 International Units (IU)/day for 6 months.
Receives: Other: RET; Dietary Supplement: Vitamin D3
RET + placeboPlacebo comparatorResistance Exercise Training (RET) + placebo given orally as tablets; 1 tablet per day for 6 months.
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lower limb extensor power (LLEP)

    Nottingham Leg Extensor Power Rig

    Measured: 6 months

Secondary outcomes (9)

  1. Body composition and bone mineral density (BMD)

    Body composition, hip and spine BMD measured using dual-energy X-ray absorptiometry (DXA)

    Measured: 6 months

  2. Short Physical Performance Battery (SPPB)

    Gait speed, chair stand, balance tests

    Measured: 6 months

  3. Timed-up-and-go (TUG)

    To assess mobility

    Measured: 6 months

  4. Physical activity

    Directly monitored physical activity using accelerometry (ActivPAL)

    Measured: 6 months

  5. Falls as events

    Incidence of falls

    Measured: 6 months

  6. Quality of life (QoL)

    QoL assessed via questionnaire

    Measured: 6 months

  7. Serum blood monitoring

    Venepuncture for markers of inflammation plus monitoring of serum vitamin D3 and calcium status at baseline, 1, 3 and 6 months.

    Measured: 6 months

  8. Muscle power

    Chair rise test using Leonardo Mechanograph Ground Reaction Force Plate

    Measured: 6 months

  9. 3-day Dietary analysis

    3-day food diary record

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2015 (estimated)
  2. Study start1 Jan 2017
  3. Primary completion31 Oct 2019
  4. Study completion16 Dec 2019

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02467153
Sponsor's protocol ID
RG_14-185
Acronym
EXVITD
Status last verified
Mar 2021
First submitted
11 May 2015
Last updated
10 Feb 2022
Results posted
No
Data monitoring committee
No

Publications

  • Welford AE, Lanham-New S, Lord J, Doyle A, Robinson J, Nightingale P, Gittoes N, Greig CA. Influence of combined vitamin D3 supplementation and resistance exercise training on musculoskeletal health in older men and women (EXVITD): protocol for a randomised controlled trial. BMJ Open. 2020 Mar 18;10(3):e033824. doi: 10.1136/bmjopen-2019-033824.

    PubMed 32193264

Questions about this trial

What is this clinical trial studying?

A study testing RET and Vitamin D3 in people with Sarcopenia and Muscle Atrophy, run by University of Birmingham at 1 site in United Kingdom.

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 17 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 10 Feb 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 Kingdom. 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?

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?

Lower limb extensor power (LLEP) (time frame: 6 months). 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 NCT02467153, 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 10 Feb 2022.

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