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Completed

NCT Number: NCT05880030

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

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.

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Key information

Conditions

Inflammation; Muscle Healthy Ineffective Erythropoiesis Inflammation Iron Metabolism Muscular Diseases Musculoskeletal Diseases Myositis Myositis, Inclusion Body Nervous System Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

28 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

Subjects were randomized to two groups: the experimental one, n = 20 and the placebo one, n = 20 with the same age, experience in running and 25(OH)D level. The experimental group received vitamin D3 supplementation (around 10,000 UI/day, i.e., 20 droplets -Vigantol medicament, Merck) and the control group received a placebo (20 droplets of sunflower oil, placed in an identical bottle as vitamin D3) for two weeks before a run. The last vitamin D dose was taken 24 h before the 100 km ultra-marathon. 40 male athletes took part in the 100 km ultra-marathon. Blood was collected before (day 0) and after supplementation (day 14). Next (day 15): before, after 25, 50, 75,100 km running and 12 hours after the run (day 16). The data were subjected to statistical analysis.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • male
  • athletes running ultra-marathons

Exclusion criteria

  • 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)

Treatment and study plan

Cholecalciferol

Drug

cholecalciferol 10000 UI

Other names: Vitamin D3

Placebo

Other

sunflower oil

Primary outcomes

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

    Time frame: Day 0 to day 14

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

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

    Time frame: Day 0 to day 14

    Measured parameter: parathyroid hormone [pg/ml].

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

    Time frame: Day "15 - the run" and day "16 - 12 hours after the 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).

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

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

    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).

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

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

    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).

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

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

    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).

Secondary outcomes

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

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

    Measured parameters of iron metabolism: hepcidin [ng/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).

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

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

    Measured serum iron level [µg/dL].Collected blood samples before and after 25, 50, 75 and 100-km run (05 11 2016) and 12h after the run (06 11 2016).

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

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

    Measured parameters of iron metabolism: ferritin [ng/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).

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

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

    Measured erythrocytes level [T/l].Collected blood samples before and after 25, 50, 75 and 100-km run (05 11 2016) and 12 hours after the run (06 11 2016).

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

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

    Measured reticulocytes [promil]. Collected blood samples before and after 25, 50, 75 and 100-km run (05 11 2016) and 12 hours after the run (06 11 2016).

  6. Observation of changes in hematocrit induced by a 100 km run.

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

    Measured hematocrit [%].Collected blood samples before and after 25, 50, 75 and 100-km run (05 11 2016) and 12 hours after the run (06 11 2016).

  7. Observation of changes in erythropoietin level induced by a 100 km run.

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

    Measured erythropoietin level [mIU - milli-International unit/mL]. Collected blood samples before and after 25, 50, 75 and 100-km run (05 11 2016) and 12 hours after the run (06 11 2016).

  8. Observation of changes in erythroferrone level induced by a 100 km run.

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

    Measured erythroferrone level [pg/ml]. Collected blood samples before and after 25, 50, 75 and 100-km run (05 11 2016) and 12 hours after the run (06 11 2016).

Sponsors and collaborators

Lead sponsor

Gdansk University of Physical Education and Sport

Other

Registry information

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
May 30, 2023
Registry last updated
May 30, 2023

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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