Strenght Training in Osteoporosis Prevention (SPORT)

December 9, 2024 updated by: Mateusz Karnia

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Gdańsk, Poland, 80-314
        • University of Gdańsk, Faculty of Biology
    • Pomorskie
      • Gdańsk, Pomorskie, Poland, 80-314
        • University of Gdańsk, Faculty of Biology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age over 50
  • female

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin D3 supplementation
Group receiving vitamin D3 at a dose of 4000 IU / day
Dietary supplement: Supplementation of vitamin D3
Supplementation of vitamin d3 at a dose of 4000 iu / day
Placebo Comparator: Placebo supplementation
Vegetable oil as a placebo.
Dietary supplement: Placebo
Vegetable oil as a placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measurement evaluating the levels of selected vitamin D3 metabolites by LC-MS.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mateusz Karnia

Investigators

  • Principal Investigator: Mateusz Karnia, PhD, University of Gdansk

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2024

Primary Completion (Actual)

October 30, 2024

Study Completion (Estimated)

January 30, 2026

Study Registration Dates

First Submitted

November 8, 2024

First Submitted That Met QC Criteria

December 9, 2024

First Posted (Estimated)

December 13, 2024

Study Record Updates

Last Update Posted (Estimated)

December 13, 2024

Last Update Submitted That Met QC Criteria

December 9, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Komisja Bioetyczna-47/23
  • NdS-II/SP/0449/2024/0 (Other Grant/Funding Number: The Polish Ministry of Science and Higher Education)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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