Clinical trial NCT05880030: The Effect of Supplementation of Vitamin D3 on Inflammation Induced by 100 km Running, Iron Metabolism and Erythropoiesis
Official title: The Effect of Supplementation of Vitamin D3 on Inflammation Induced by 100 km Running, Iron Metabolism and Erythropoiesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation; Muscle
Iron Metabolism
Ineffective Erythropoiesis
Healthy
Keywords: Vitamin D
Running
inflammations
erythropoietin
iron
hepcidin
Lead sponsor: Gdansk University of Physical Education and Sport
Sponsor class: OTHER
First posted: 2023-05-30
Enrollment: 40
Sex: MALE
Minimum age (years): 28
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: The change in vitamin 25(OH)D level after two-week supplementation.
timeFrame: Day 0 to day 14
measure: The change in parathyroid hormone level after two-week supplementation.
timeFrame: Day 0 to day 14
measure: Observation of changes in inflammatory parameters:interleukin-6 induced by a 100 km run
timeFrame: Day "15 - the run" and day "16 - 12 hours after the run"
measure: Observation of changes in inflammatory parameters: C reactive protein - CRP induced by 100 km running.
timeFrame: Day "15 - the run" and day "16 - 12 hours after the run"
measure: Observation of changes in creatine kinase level induced by 100 km running.
timeFrame: Day "15 - the run" and day "16 - 12 hours after the run"
measure: Observation of changes in leucocytes induced by 100 km running.
timeFrame: Day "15 - the run" and day "16 - 12 hours after the run"
Secondary outcomes:
measure: Observation of changes in hepcidin level induced by 100 km running.
timeFrame: Day "15 - the run" and day "16 - 12 hours after the run"
measure: Observation of changes in serum iron level induced by 100 km running.
timeFrame: Day "15 - the run" and day "16 - 12 hours after the run"
measure: Observation of changes in ferritin induced by 100 km running.
timeFrame: Day "15 - the run" and day "16 - 12 hours after the run"
measure: Observation of changes in erythrocytes level induced by a 100 km run.
timeFrame: Day "15 - the run" and day "16 - 12 hours after the run"
measure: Observation of changes in reticulocytes induced by a 100 km run.
timeFrame: Day "15 - the run" and day "16 - 12 hours after the run"
measure: Observation of changes in hematocrit induced by a 100 km run.
timeFrame: Day "15 - the run" and day "16 - 12 hours after the run"
measure: Observation of changes in erythropoietin level induced by a 100 km run.
timeFrame: Day "15 - the run" and day "16 - 12 hours after the run"
measure: Observation of changes in erythroferrone level induced by a 100 km run.
timeFrame: Day "15 - the run" and day "16 - 12 hours after the run"
Other outcomes:
Locations:
Study officials:
affiliation: Gdansk University of Physical Education and Sport
name: Katarzyna Kasprowicz, PhD
role: STUDY_CHAIR
References: