Muscle StrengthNCT01252381
Supplementary Intake of Vitamin D During 12 Weeks Strength Training in Younger and Older People
A study testing 12 weeks Strength exercise training in people with Muscle Strength and Tendon Elasticity, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The aim is to investigate the importance of vitamin D levels to achieve the effect of strength training. If we can show that vitamin D has an effect of training, the ultimate goal is to find out why and how vitamin D affects muscle. This would potentially have important implications for public health. Read more about this study
- Who is it for?
- Ages 20 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Strength, Tendon Elasticity, Muscle CSA
- What is being tested?
- 12 weeks Strength exercise training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2010to Jan 2013
- 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 20 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men 20-30 or 60-75 years old
Who cannot join
- smokers Knee problems On medication affecting protein synthesis High exposure to sun light (ex. ski holiday) during the trial
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Institute of Sports Medicine - Bispebjerg Hospital
Copenhagen, DK-2400
About this study
Official title: The Importance of Supplementary Intake of Vitamin D on the Efficacy of 12 Weeks of Strength Training in Both Vitamin D Sufficient Younger and Older People
The aim is to investigate the importance of vitamin D levels to achieve the effect of strength training. If we can show that vitamin D has an effect of training, the ultimate goal is to find out why and how vitamin D affects muscle.
This would potentially have important implications for public health. Since a large number of populations, including elderly, are shown to have too little vitamin D and also has low muscle strength, it will be essential that these people added vitamin D in relation to training and rehabilitation.
- Conditions
- Muscle Strength, Tendon Elasticity, Muscle CSA, Tendon CSA, VDR Receptor
- Being tested
- 12 weeks Strength exercise training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12 weeks Strength exercise trainingOther
Training 3 times a week, leg extensions and leg press
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Active comparator | Not described Receives: Other: 12 weeks Strength exercise training |
| Calcium tablet | Placebo comparator | Not described Receives: Other: 12 weeks Strength exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross-sectional area of thigh musculature and knee tendon
Measured: 12 weeks
VDR potential target CYP27b1
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionFeb 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle StrengthStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Sports Medicine, Copenhagen
- Responsible party
- Principal investigator, Jakob Agergaard, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01252381
- Sponsor's protocol ID
- BBH 77
- Status last verified
- Jul 2017
- First submitted
- 2 Dec 2010
- Last updated
- 5 Jul 2017
- Results posted
- No
Publications
Agergaard J, Trostrup J, Uth J, Iversen JV, Boesen A, Andersen JL, Schjerling P, Langberg H. Does vitamin-D intake during resistance training improve the skeletal muscle hypertrophic and strength response in young and elderly men? - a randomized controlled trial. Nutr Metab (Lond). 2015 Sep 30;12:32. doi: 10.1186/s12986-015-0029-y. eCollection 2015.
PubMed 26430465
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Importance of Supplementary Intake of Vitamin D on the Efficacy of 12 Weeks of Strength Training in Both Vitamin D Sufficient Younger and Older People
- ClinicalTrials.gov ID
- NCT01252381
- Acronym / sponsor ID
- BBH 77
- Conditions
- Muscle Strength, Tendon Elasticity, Muscle CSA, Tendon CSA, VDR Receptor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Institute of Sports Medicine, Copenhagen
- Study start
- Nov 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 3 Dec 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.
The aim is to investigate the importance of vitamin D levels to achieve the effect of strength training. If we can show that vitamin D has an effect of training, the ultimate goal is to find out why and how vitamin D affects muscle.
This would potentially have important implications for public health. Since a large number of populations, including elderly, are shown to have too little vitamin D and also has low muscle strength, it will be essential that these people added vitamin D in relation to training and rehabilitation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Active comparator | Other: 12 weeks Strength exercise training |
| Calcium tablet | Placebo comparator | Other: 12 weeks Strength exercise training |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men 20-30 or 60-75 years old
Key exclusion criteria (1 listed)
- smokers Knee problems On medication affecting protein synthesis High exposure to sun light (ex. ski holiday) during the trial
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 |
|---|---|---|
| 12 weeks Strength exercise trainingTraining 3 times a week, leg extensions and leg press | Other | Calcium tablet, Vitamin D |
Primary outcome
Cross-sectional area of thigh musculature and knee tendon
Time frame: 12 weeks
VDR potential target CYP27b1
Time frame: 12 weeks
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 5 Jul 2017.
- Derived from this study: PubMed 26430465Agergaard J, Trostrup J, Uth J, Iversen JV, Boesen A, Andersen JL, Schjerling P, Langberg H. Does vitamin-D intake during resistance training improve the skeletal muscle hypertrophic and strength response in young and elderly men? - a randomized controlled trial. Nutr Metab (Lond). 2015 Sep 30;12:32. doi: 10.1186/s12986-015-0029-y. eCollection 2015.
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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 12 weeks Strength exercise training in people with Muscle Strength and Tendon Elasticity, run by Bispebjerg Hospital at 1 site in Denmark.
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 1 inclusion and 1 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 5 Jul 2017. 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 Denmark. 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?
Cross-sectional area of thigh musculature and knee tendon (time frame: 12 weeks). 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 NCT01252381, 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 5 Jul 2017.