Strenght Training in Osteoporosis Prevention

NCT ID: NCT06733064

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-02

Study Completion Date

2026-01-30

Brief Summary

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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.

Detailed Description

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Conditions

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Osteopenia or Osteoporosis

Keywords

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strenght training vitamin d3 osteoporosis osteopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Vitamin D3 supplementation

Group receiving vitamin D3 at a dose of 4000 IU / day

Group Type EXPERIMENTAL

Supplementation of vitamin D3

Intervention Type DIETARY_SUPPLEMENT

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

Placebo supplementation

Vegetable oil as a placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Vegetable oil as a placebo

Interventions

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Supplementation of vitamin D3

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Vegetable oil as a placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mateusz Karnia

OTHER

Sponsor Role lead

Responsible Party

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Mateusz Karnia

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mateusz Karnia, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Gdansk

Locations

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University of Gdańsk, Faculty of Biology

Gdansk, Pomeranian Voivodeship, Poland

Site Status

University of Gdańsk, Faculty of Biology

Gdansk, , Poland

Site Status

Countries

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Poland

Related Links

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Other Identifiers

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NdS-II/SP/0449/2024/0

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Komisja Bioetyczna-47/23

Identifier Type: -

Identifier Source: org_study_id