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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05880030

Enrollment

Registered

2023-05-30

Start date

2016-10-19

Completion date

2022-12-31

Last updated

2023-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Ineffective Erythropoiesis, Inflammation; Muscle, Iron Metabolism

Keywords

Vitamin D, Running, inflammations, erythropoietin, iron, hepcidin

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.

Interventions

DRUGCholecalciferol

cholecalciferol 10000 UI

OTHERplacebo

sunflower oil

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Outcomes Assessor)

Masking description

Both groups took drops from the same dark bottles, 20 drops per day for two weeks.

Eligibility

Sex/Gender

MALE

Age

28 Years to 64 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
The change in vitamin 25(OH)D level after two-week supplementation.	Day 0 to day 14	Measured parameter: vitamin 25(OH)D \[ng/ml\].
The change in parathyroid hormone level after two-week supplementation.	Day 0 to day 14	Measured parameter: parathyroid hormone \[pg/ml\].
Observation of changes in inflammatory parameters:interleukin-6 induced by a 100 km run	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).
Observation of changes in inflammatory parameters: C reactive protein - CRP induced by 100 km running.	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).
Observation of changes in creatine kinase level induced by 100 km running.	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).
Observation of changes in leucocytes induced by 100 km running.	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

Measure	Time frame	Description
Observation of changes in erythropoietin level induced by a 100 km run.	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).
Observation of changes in hepcidin level induced by 100 km running.	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).
Observation of changes in erythroferrone level induced by a 100 km run.	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).
Observation of changes in serum iron level induced by 100 km running.	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).
Observation of changes in ferritin induced by 100 km running.	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).
Observation of changes in erythrocytes level induced by a 100 km run.	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).
Observation of changes in reticulocytes induced by a 100 km run.	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).
Observation of changes in hematocrit induced by a 100 km run.	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).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026