Osteopenia or OsteoporosisSPORTNCT06733064
Strenght Training in Osteoporosis Prevention
A study testing Supplementation of vitamin D3 in people with Osteopenia or Osteoporosis, run by Mateusz Karnia at 2 sites in Poland.
Trial summary
The study involves 120 women over the age of 50. All participants in the study take part in high-intensity strength training for 10 months. In addition, half of the participants receive vitamin D3 at a dose of 4,000 IU/day. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Osteopenia or Osteoporosis
- What is being tested?
- Supplementation of vitamin D3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesPoland
- Study dates
- 2 Sep 2024to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age over 50
- female
Who cannot join
- ongoing cancer,
- unstabilized cardiovascular disease,
- cognitive disorders,
- radiological treatment in the last 12 months,
- other contraindications to undertaking high-intensity strength training,
- diseases affecting the skeleton such as: Paget's disease, type I diabetes mellitus,
- taking medications affecting skeletal conditions including: long-term therapy with corticosteroids, thiazides, antiretroviral drugs,
- contraindications to taking vitamin D including: hypercalcemia, nephrolithiasis, sarcoidosis, lack of cholecalciferol hydroxylase activity in the liver and kidneys.
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
University of Gdańsk, Faculty of Biology
Gdansk, Pomeranian Voivodeship, 80-314
University of Gdańsk, Faculty of Biology
Gdansk, 80-314
About this study
Official title: Effective Prevention of Osteoporosis Through Rehabilitation and Training
The study involves 120 women over the age of 50.
All participants in the study take part in high-intensity strength training for 10 months.
In addition, half of the participants receive vitamin D3 at a dose of 4,000 IU/day.
The investigators hypothesize that training combined with vitamin D3 supplementation will be more effective in preventing osteoporosis than training alone.
- Conditions
- Osteopenia or Osteoporosis
- Being tested
- Supplementation of vitamin D3, Placebo
- Keywords
- strenght training, vitamin d3, osteoporosis, osteopenia
- Medical subject headings
- Bone Diseases, Metabolic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplementation of vitamin D3Dietary supplement
Supplementation of vitamin d3 at a dose of 4000 iu / day
PlaceboDietary supplement
Vegetable oil as a placebo
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 supplementation | Experimental | Group receiving vitamin D3 at a dose of 4000 IU / day Receives: Dietary Supplement: Supplementation of vitamin D3 |
| Placebo supplementation | Placebo comparator | Vegetable oil as a placebo. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density
Test to determine bone mineral density by densitometry.
Measured: Measured at 3 time points: before the experiment, after 10 months of training, and at 6 months after the end of training and supplementation.
Secondary outcomes (1)
Vitamin D metabolites level
Measurement evaluating the levels of selected vitamin D3 metabolites by LC-MS.
Measured: Measured at 4 time points: before the experiment, after 5 and 10 months of training, and at 6 months after the end of training and supplementation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start2 Sep 2024
- Primary completion30 Oct 2024
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteopenia or OsteoporosisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mateusz Karnia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mateusz Karnia, University of Gdansk
- Investigators
- Mateusz Karnia, PhD, Principal investigator, University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733064
- Sponsor's protocol ID
- Komisja Bioetyczna-47/23
- Other IDs
- NdS-II/SP/0449/2024/0
- Acronym
- SPORT
- Status last verified
- Nov 2024
- First submitted
- 8 Nov 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Prevention of Osteoporosis Through Rehabilitation and Training
- ClinicalTrials.gov ID
- NCT06733064
- Acronym / sponsor ID
- SPORT / Komisja Bioetyczna-47/23
- Conditions
- Osteopenia or Osteoporosis
- Keywords
- strenght training, vitamin d3, osteoporosis, osteopenia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Mateusz KarniaUniversity, hospital or other
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 13 Dec 2024 (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 study involves 120 women over the age of 50.
All participants in the study take part in high-intensity strength training for 10 months.
In addition, half of the participants receive vitamin D3 at a dose of 4,000 IU/day.
The investigators hypothesize that training combined with vitamin D3 supplementation will be more effective in preventing osteoporosis than training alone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 supplementation | Experimental | Dietary Supplement: Supplementation of vitamin D3Group receiving vitamin D3 at a dose of 4000 IU / day |
| Placebo supplementation | Placebo comparator | Dietary Supplement: PlaceboVegetable oil as a placebo. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age over 50
- female
Key exclusion criteria (8 listed)
- ongoing cancer,
- unstabilized cardiovascular disease,
- cognitive disorders,
- radiological treatment in the last 12 months,
- other contraindications to undertaking high-intensity strength training,
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 |
|---|---|---|
| Supplementation of vitamin D3Supplementation of vitamin d3 at a dose of 4000 iu / day | Dietary supplement | Vitamin D3 supplementation |
| PlaceboVegetable oil as a placebo | Dietary supplement | Placebo supplementation |
Primary outcome
Bone Mineral Density
Time frame: Measured at 3 time points: before the experiment, after 10 months of training, and at 6 months after the end of training and supplementation.
Test to determine bone mineral density by densitometry.
1 secondary outcome
Vitamin D metabolites level
Time frame: Measured at 4 time points: before the experiment, after 5 and 10 months of training, and at 6 months after the end of training and supplementation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Mateusz Karnia, PhD principal investigator
University of Gdansk
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplementation of vitamin D3 in people with Osteopenia or Osteoporosis, run by Mateusz Karnia at 2 sites in Poland.
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 8 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: under way, not looking for participants, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. 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?
This study is still under way. Results are not available in the source record yet.
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?
Bone Mineral Density (time frame: Measured at 3 time points: before the experiment, after 10 months of training, and at 6 months after the end of training and supplementation.). 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 Dec 2024.