The Effect of Supplementation of Vitamin D3 on Inflammation Induced by 100 km Running, Iron Metabolism and Erythropoiesis

NCT05880030 | Completed

• 1 other identifier: AWFiS/2022_2_MK
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

A group of runners received vitamin D (10,000 IU - international unit per day) for two weeks. The aim of the intervention was to check the effect of vitamin D supplementation on selected parameters of inflammation and iron metabolism in comparison with the placebo group. Blood was collected before and after supplementation. Next: before, after 25, 50, 75,100 km running and 12 hours after the run. The data were subjected to statistical analysis.

Conditions

Inflammation; Muscle; Iron Metabolism; Ineffective Erythropoiesis; Healthy

Keywords

Vitamin D; Running; inflammations; erythropoietin; iron; hepcidin

Outcome Measures

Primary Outcomes (6)

• The change in vitamin 25(OH)D level after two-week supplementation.

  Measured parameter: vitamin 25(OH)D \[ng/ml\].

  Day 0 to day 14

• The change in parathyroid hormone level after two-week supplementation.

  Measured parameter: parathyroid hormone \[pg/ml\].

  Day 0 to day 14

• Observation of changes in inflammatory parameters:interleukin-6 induced by a 100 km run

  Measured parameter of inflammatory: interleukin-6 \[pg/ml\]. Collected blood samples before and after 25, 50, 75 and 100-km run (05 11 2016) and 12h after the run (06 11 2016).

  Day "15 - the run" and day "16 - 12 hours after the run"

• Observation of changes in inflammatory parameters: C reactive protein - CRP induced by 100 km running.

  Measured parameter of inflammatory: CRP\[mg/l\]. Collected blood samples before and after 25, 50, 75 and 100-km run (05 11 2016) and 12h after the run (06 11 2016).

  Day "15 - the run" and day "16 - 12 hours after the run"

• Observation of changes in creatine kinase level induced by 100 km running.

  Measured parameter: creatine kinase \[U/l\]. Collected blood samples before and after 25, 50, 75 and 100-km run (05 11 2016) and 12h after the run (06 11 2016).

  Day "15 - the run" and day "16 - 12 hours after the run"

• Observation of changes in leucocytes induced by 100 km running.

  Measured parameters of inflammatory: leukocytes \[G/l\]. Collected blood samples before and after 25, 50, 75 and 100-km run (05 11 2016) and 12h after the run (06 11 2016).

  Day "15 - the run" and day "16 - 12 hours after the run"

Secondary Outcomes (8)

• Observation of changes in hepcidin level induced by 100 km running.

  Day "15 - the run" and day "16 - 12 hours after the run"

• Observation of changes in serum iron level induced by 100 km running.

  Day "15 - the run" and day "16 - 12 hours after the run"

• Observation of changes in ferritin induced by 100 km running.

  Day "15 - the run" and day "16 - 12 hours after the run"

• Observation of changes in erythrocytes level induced by a 100 km run.

  Day "15 - the run" and day "16 - 12 hours after the run"

• Observation of changes in reticulocytes induced by a 100 km run.

  Day "15 - the run" and day "16 - 12 hours after the run"

Study Arms (2)

Vitamin D

ACTIVE COMPARATOR

Vigantol 10 000 IU/day (20 droplets) two weeks supplementation (vitamin D3)

Drug: Cholecalciferol

Control

PLACEBO COMPARATOR

sunflower oil, (20 droplets) two weeks supplementation.

Other: placebo

Interventions

Cholecalciferol DRUG

cholecalciferol 10000 UI

Also known as: Vitamin D3

Vitamin D

placebo OTHER

sunflower oil

Control

Eligibility Criteria

• Age: 28 Years - 64 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• male
• athletes running ultra-marathons

You may not qualify if:

• vitamin D3 supplementation
• multivitamin and iron supplementation
• serum 25(OH)D low \< 10 ng/mL
• serum 25(OH)D high \> 100 ng/mL
• haemoglobin \< 10 g/dL
• other (sports injury, tournament)

Sponsors & Collaborators

• Gdansk University of Physical Education and Sport: lead

MeSH Terms

Conditions

Myositis, Inclusion Body; Inflammation

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Myositis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Katarzyna Kasprowicz, PhD

  Gdansk University of Physical Education and Sport

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Both groups took drops from the same dark bottles, 20 drops per day for two weeks.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: May 30, 2023
• Study Start: October 19, 2016
• Primary Completion: November 1, 2022
• Study Completion: December 31, 2022
• Last Updated: May 30, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share