AgingNCT04341818
Vitamin D and Resistance Exercise in Elderly (NUTRIAGINGVitD)
A study testing Strength Training and Vitamin D monthly, Strength Training and Vitamin D daily and Strength Training and no Vitamin D in people with Aging, run by University of Vienna at 1 site in Austria.
Trial summary
The aim of this randomized, double-blind, controlled intervention study with parallel groups is to investigate the effect of resistance training (2x/week for 10 weeks) with and without different goals of vitamin D intake on muscle strength, function and mass, oxidative stress parameters and the immune system in… Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Strength Training and Vitamin D monthly, Strength Training and Vitamin D daily and Strength Training and no Vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- 15 Jan 2019to Dec 2021
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Males and females between the age of 65 and 85 years
- Adequate mental condition in order to follow the instructions and to perform the resistance exercise independently (Mini-Mental-State >23)
- Independently mobile
Who cannot join
- Chronic diseases, which contraindicate a training participation
- Serious cardiovascular diseases (congestive chronic heart failure, severe or symptomatic aortic stenosis, unstable angina pectoris, untreated arterial hypertension, cardiac arrhythmias)
- Diabetic retinopathy
- Manifest osteoporosis
- Regular use of cortisone-containing drugs
- Regular strength training (> 1x / week) in the last 6 months before inclusion
- Vitamin D plasma level of 75 nmol/l or above
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin D and Resistance Exercise in Elderly
The aim of this randomized, double-blind, controlled intervention study with parallel groups is to investigate the effect of resistance training (2x/week for 10 weeks) with and without different goals of vitamin D intake on muscle strength, function and mass, oxidative stress parameters and the immune system in community dwelling persons. Participants (n = 100) will be community-dwelling older adults. After a preparticipation screening and a vitamin D blood investigation (vitamin D status below 75 nmol/L) participants will be distributed randomly but stratified by sex, age and initial vitamin D plasma levels to one of the 3 groups (Vitamin D daily + strength training, Vitamin D monthly + strength training, no Vitamin D + strength training).
Study participants are eligible if they are male or female with an age between 65 and 85 years and if their cognitive status as well as their physical fitness level allows to participate at the strength training sessions. Exclusion criteria comprise chronic diseases which contraindicate the training sessions, serious cardiovascular disease, diabetic retinopathy and manifest osteoporosis, a frailty index at or above 3, medication with anticoagulants or cortisone drugs, a regular strength training during the last six months and a vitamin D plasma concentration of 75nmol/L or above.
Primary outcome measure is the change in the handgrip strength. Secondary outcome measures comprise anthropometric data, functional performance tests, immunological and oxidative stress parameters, DNA/Chromosomal damage microbiota, metabolomics and the nutritional status.
- Conditions
- Aging
- Being tested
- Strength Training and Vitamin D monthly, Strength Training and Vitamin D daily, Strength Training and no Vitamin D
- Keywords
- aging, vitamin D, resistance training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength Training and Vitamin D monthlyOther
For 4 wks 50.000 IU vitamin D is given as a monthly dose together with daily 400mg of calcium. Both as a supplement, followed by a 10 weeks resistance training (progressive strength training in a fitness center is applied; the intensity is adjusted continuously in order to obtain a sufficient training stimulus). During the training period the vitamin D and calcium intake remain.
Strength Training and Vitamin D dailyOther
For 4 wks 800 IU vitamin D is given as a daily dose together with daily 400mg of calcium. Both as a supplement, followed by a 10 weeks resistance training (progressive strength training in a fitness center is applied; the intensity is adjusted continuously in order to obtain a sufficient training stimulus). During the training period the vitamin D and calcium intake remain.
Strength Training and no Vitamin DOther
For 4 wks no vitamin D is administered, followed by a 10 weeks resistance training (progressive strength training in a fitness center is applied; the intensity is adjusted continuously in order to obtain a sufficient training stimulus). During the training period the also no vitamin D is given. Over the whole study period participants get 400 mg calcium/day.
| Study group | Role | What they receive |
|---|---|---|
| Strength Training and Vitamin D monthly | Experimental | Four weeks of Vitamin D (50.000 IU once per month) followed by a 10 week guided resistance training (progressive strength training in a fitness center is applied; the intensity is adjusted continuously in order to obtain a sufficient training stimulus). During the training period the vitamin D intake remains. Over the whole study period participants get 400 mg calcium/day. Receives: Other: Strength Training and Vitamin D monthly |
| Strength Training and Vitamin D daily | Experimental | Four weeks of Vitamin D (800 IU once per day) followed by a 10 week guided resistance training (progressive strength training in a fitness center is applied; the intensity is adjusted continuously in order to obtain a sufficient training stimulus). During the training period the vitamin D intake remains. Over the whole study period participants get 400 mg calcium/day. Receives: Other: Strength Training and Vitamin D daily |
| Strength Training and no Vitamin D | Experimental | Four weeks of no vitamin D administration followed by a 10 week guided resistance training (progressive strength training in a fitness center is applied; the intensity is adjusted continuously in order to obtain a sufficient training stimulus). During the training period the vitamin D intake remains. Over the whole study period participants get 400 mg calcium/day. Receives: Other: Strength Training and no Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in handgrip strength (kg)
Handgrip strength of the right hand will be measured to the nearest kilogram (kg) using a hand Dynamometer. Participants will be encouraged to perform a maximal contraction within approximately 4 to 5 s. After a rest of 60 s, participants will be asked to perform a second trial. The highest score of maximum voluntary contraction will be used for data analyses.
Measured: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Secondary outcomes (12)
Change from baseline in chair stand test (repetitions within 30s)
The maximum number of completed cycles of unsupported chair rises (from a seated to a fully erected position (hip and knees straightened)) completed within 30 s is counted automatically (Leonardo Mechanography). Force, acceleration, power, kinetic energy, potential energy, mass, total duration, time per iteration are reported as secondary parameters.
Measured: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Change from baseline in muscle mass with BIA (kg)
Measured: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Change from baseline in 6min walking test (distance in meter)
Participants are instructed to walk alone as quickly as possible (without running) around a 30 m shuttle course as many times as possible within the time limit of 6 mins.
Measured: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Change from baseline in the composition of gut-microbiota
Gene sequencing of the 16S rRNA on the stool samples are performed to identify the microbes down to genus level as well as the microbial diversity and relative abundance.
Measured: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Change from baseline in stool short-chain fatty acids (SCFAs)
The stool short-chain fatty acids (SCFAs) will be extracted and quantitatively analysed by gas chromatography.
Measured: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Change from baseline in oxidative stress marker such as malondialdehyde
The investigators will consider changes in plasma concentrations of oxidative stress marker such as malondialdehyde.
Measured: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Change from baseline in inflammatory marker (i.g. IL-6, TNF-alpha)
The investigators will consider changes in plasma concentrations of Interleukin 1 (IL-1), IL-6, IL-8, IL-10, TNF-alpha
Measured: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Change from baseline in the metabolomic response
The metabolomic response (ie all metabolites) to the interventions will be analyzed using both nuclear magnetic resonance (NMR) and mass spectrometry (MS) techniques. Patterns of metabolites will be evaluated with statistical techniques, ie discriminant analysis and principal component analysis.
Measured: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Change from baseline in the amino acid pattern
The plasma amino acid pattern will be assessed with HPLC-MS.
Measured: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Change from baseline in DNA damage (%DNA in the tail)
DNA damage will be assessed in lymphocytes, whole blood and urine in response to the interventions.
Measured: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Change from baseline in chromosomal damage (number of micronuclei/1000 binucleated cells)
Chromosomal damage will be assessed in lymphocytes in response to the interventions.
Measured: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Change from baseline in RDA and DNA gene expression
RNA and DNA gene expression will be assessed in response to the interventions.
Measured: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start15 Jan 2019
- Primary completion20 Aug 2019
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karl-Heinz Wagner, University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341818
- Sponsor's protocol ID
- FA219002_2
- Status last verified
- Apr 2020
- First submitted
- 7 Apr 2020
- Last updated
- 13 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D and Resistance Exercise in Elderly
- ClinicalTrials.gov ID
- NCT04341818
- Acronym / sponsor ID
- FA219002_2
- Conditions
- Aging
- Keywords
- aging, vitamin D, resistance training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of ViennaUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 20 Aug 2019 (actual)
- Study completion
- Dec 2021 (estimated)
- First posted
- 10 Apr 2020 (actual)
- 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 aim of this randomized, double-blind, controlled intervention study with parallel groups is to investigate the effect of resistance training (2x/week for 10 weeks) with and without different goals of vitamin D intake on muscle strength, function and mass, oxidative stress parameters and the immune system in community dwelling persons. Participants (n = 100) will be community-dwelling older adults. After a preparticipation screening and a vitamin D blood investigation (vitamin D status below 75 nmol/L) participants will be distributed randomly but stratified by sex, age and initial vitamin D plasma levels to one of the 3 groups (Vitamin D daily + strength training, Vitamin D monthly + strength training, no Vitamin D + strength training).
Study participants are eligible if they are male or female with an age between 65 and 85 years and if their cognitive status as well as their physical fitness level allows to participate at the strength training sessions. Exclusion criteria comprise chronic diseases which contraindicate the training sessions, serious cardiovascular disease, diabetic retinopathy and manifest osteoporosis, a frailty index at or above 3, medication with anticoagulants or cortisone drugs, a regular strength training during the last six months and a vitamin D plasma concentration of 75nmol/L or above.
Primary outcome measure is the change in the handgrip strength. Secondary outcome measures comprise anthropometric data, functional performance tests, immunological and oxidative stress parameters, DNA/Chromosomal damage microbiota, metabolomics and the nutritional status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Strength Training and Vitamin D monthly | Experimental | Other: Strength Training and Vitamin D monthlyFour weeks of Vitamin D (50.000 IU once per month) followed by a 10 week guided resistance training (progressive strength training in a fitness center is applied; the intensity is adjusted continuously in order to obtain a sufficient training stimulus). During the training period the vitamin D intake remains. Over the whole study period participants get 400 mg calcium/day. |
| Strength Training and Vitamin D daily | Experimental | Other: Strength Training and Vitamin D dailyFour weeks of Vitamin D (800 IU once per day) followed by a 10 week guided resistance training (progressive strength training in a fitness center is applied; the intensity is adjusted continuously in order to obtain a sufficient training stimulus). During the training period the vitamin D intake remains. Over the whole study period participants get 400 mg calcium/day. |
| Strength Training and no Vitamin D | Experimental | Other: Strength Training and no Vitamin DFour weeks of no vitamin D administration followed by a 10 week guided resistance training (progressive strength training in a fitness center is applied; the intensity is adjusted continuously in order to obtain a sufficient training stimulus). During the training period the vitamin D intake remains. Over the whole study period participants get 400 mg calcium/day. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Males and females between the age of 65 and 85 years
- Adequate mental condition in order to follow the instructions and to perform the resistance exercise independently (Mini-Mental-State >23)
- Independently mobile
Key exclusion criteria (7 listed)
- Chronic diseases, which contraindicate a training participation
- Serious cardiovascular diseases (congestive chronic heart failure, severe or symptomatic aortic stenosis, unstable angina pectoris, untreated arterial hypertension, cardiac arrhythmias)
- Diabetic retinopathy
- Manifest osteoporosis
- Regular use of cortisone-containing drugs
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 |
|---|---|---|
| Strength Training and Vitamin D monthlyFor 4 wks 50.000 IU vitamin D is given as a monthly dose together with daily 400mg of calcium. Both as a supplement, followed by a 10 weeks resistance training (progressive strength training in a fitness center is applied; the intensity is adjusted continuously in order to obtain a sufficient training stimulus). During the training period the vitamin D and calcium intake remain. | Other | Strength Training and Vitamin D monthly |
| Strength Training and Vitamin D dailyFor 4 wks 800 IU vitamin D is given as a daily dose together with daily 400mg of calcium. Both as a supplement, followed by a 10 weeks resistance training (progressive strength training in a fitness center is applied; the intensity is adjusted continuously in order to obtain a sufficient training stimulus). During the training period the vitamin D and calcium intake remain. | Other | Strength Training and Vitamin D daily |
| Strength Training and no Vitamin DFor 4 wks no vitamin D is administered, followed by a 10 weeks resistance training (progressive strength training in a fitness center is applied; the intensity is adjusted continuously in order to obtain a sufficient training stimulus). During the training period the also no vitamin D is given. Over the whole study period participants get 400 mg calcium/day. | Other | Strength Training and no Vitamin D |
Primary outcome
Change from baseline in handgrip strength (kg)
Time frame: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Handgrip strength of the right hand will be measured to the nearest kilogram (kg) using a hand Dynamometer. Participants will be encouraged to perform a maximal contraction within approximately 4 to 5 s. After a rest of 60 s, participants will be asked to perform a second trial. The highest score of maximum voluntary contraction will be used for data analyses.
12 secondary outcomes
Change from baseline in chair stand test (repetitions within 30s)
Time frame: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Change from baseline in muscle mass with BIA (kg)
Time frame: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Change from baseline in 6min walking test (distance in meter)
Time frame: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Change from baseline in the composition of gut-microbiota
Time frame: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Change from baseline in stool short-chain fatty acids (SCFAs)
Time frame: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Change from baseline in oxidative stress marker such as malondialdehyde
Time frame: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Change from baseline in inflammatory marker (i.g. IL-6, TNF-alpha)
Time frame: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Change from baseline in the metabolomic response
Time frame: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Change from baseline in the amino acid pattern
Time frame: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Change from baseline in DNA damage (%DNA in the tail)
Time frame: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Change from baseline in chromosomal damage (number of micronuclei/1000 binucleated cells)
Time frame: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Change from baseline in RDA and DNA gene expression
Time frame: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength Training and Vitamin D monthly, Strength Training and Vitamin D daily and Strength Training and no Vitamin D in people with Aging, run by University of Vienna at 1 site in Austria.
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 7 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: status not confirmed, as of the sponsor's last update on 13 Apr 2020. 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 Austria. 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?
Results are not available in the source record.
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 from baseline in handgrip strength (kg) (time frame: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 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 13 Apr 2020.