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Strenght Training in Osteoporosis Prevention (SPORT)

M

Mateusz Karnia

Status

Active, not recruiting

Conditions

Osteopenia or Osteoporosis

Treatments

Dietary Supplement: Placebo
Dietary Supplement: Supplementation of vitamin D3

Study type

Interventional

Funder types

Other

Identifiers

NCT06733064
NdS-II/SP/0449/2024/0 (Other Grant/Funding Number)
Komisja Bioetyczna-47/23

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

Female

Ages

50+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

120 participants in 2 patient groups, including a placebo group

Vitamin D3 supplementation
Experimental group
Description:
Group receiving vitamin D3 at a dose of 4000 IU / day
Treatment:
Dietary Supplement: Supplementation of vitamin D3
Placebo supplementation
Placebo Comparator group
Description:
Vegetable oil as a placebo.
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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