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Active, Not Recruiting

NCT Number: NCT06733064

Strenght Training in Osteoporosis Prevention

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Osteopenia or Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Gdańsk, Faculty of Biology, Gdansk, Pomeranian Voivodeship, Poland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supplementation of vitamin D3

Dietary Supplement

Supplementation of vitamin d3 at a dose of 4000 iu / day

Placebo

Dietary Supplement

Vegetable oil as a placebo

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Mateusz Karnia

Other

Registry information

Official study title

Effective Prevention of Osteoporosis Through Rehabilitation and Training

Acronym: SPORT

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Dec 13, 2024
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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