Strenght Training in Osteoporosis Prevention

NCT06733064 | Active Not Recruiting

• 2 other identifiers: Komisja Bioetyczna-47/23NdS-II/SP/0449/2024/0
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief 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. The investigators hypothesize that training combined with vitamin D3 supplementation will be more effective in preventing osteoporosis than training alone.

Conditions

Osteopenia or Osteoporosis

Keywords

strenght training; vitamin d3; osteoporosis; osteopenia

Outcome Measures

Primary Outcomes (1)

• Bone Mineral Density

  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 Outcomes (1)

• Vitamin D metabolites level

  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.

Study Arms (2)

Vitamin D3 supplementation

EXPERIMENTAL

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

Dietary Supplement: Supplementation of vitamin D3

Placebo supplementation

PLACEBO COMPARATOR

Vegetable oil as a placebo.

Dietary Supplement: Placebo

Interventions

Supplementation of vitamin D3 DIETARY_SUPPLEMENT

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

Vitamin D3 supplementation

Placebo DIETARY_SUPPLEMENT

Vegetable oil as a placebo

Placebo supplementation

Eligibility Criteria

• Age: 50 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age over 50
• female

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mateusz Karnia: lead

Study Sites (2)

University of Gdańsk, Faculty of Biology

Gdansk, Pomeranian Voivodeship, 80-314, Poland

Location

University of Gdańsk, Faculty of Biology

Gdansk, 80-314, Poland

Location

Related Links

• Related Info

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mateusz Karnia, PhD

  University of Gdansk

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: December 13, 2024
• Study Start: September 2, 2024
• Primary Completion: October 30, 2024
• Study Completion: January 30, 2026
• Last Updated: December 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)