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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05880030
• Other study ID #: AWFiS/2022_2_MK
• Status: Completed
• Phase: N/A
• Start date: October 19, 2016
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2022
• Source: Gdansk University of Physical Education and Sport
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 28 Years to 64 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy
• Ineffective Erythropoiesis
• Inflammation
• Inflammation; Muscle
• Iron Metabolism
• Myositis

Intervention

Drug:
• Cholecalciferol
cholecalciferol 10000 UI

Other:
• placebo
sunflower oil

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gdansk University of Physical Education and Sport

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	The change in parathyroid hormone level after two-week supplementation.	Measured parameter: parathyroid hormone [pg/ml].	Day 0 to day 14
Primary	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"
Primary	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"
Primary	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"
Primary	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	Observation of changes in hepcidin level induced by 100 km running.	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).	Day "15 - the run" and day "16 - 12 hours after the run"
Secondary	Observation of changes in serum iron level induced by 100 km running.	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).	Day "15 - the run" and day "16 - 12 hours after the run"
Secondary	Observation of changes in ferritin induced by 100 km running.	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).	Day "15 - the run" and day "16 - 12 hours after the run"
Secondary	Observation of changes in erythrocytes level induced by a 100 km 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).	Day "15 - the run" and day "16 - 12 hours after the run"
Secondary	Observation of changes in reticulocytes induced by a 100 km 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).	Day "15 - the run" and day "16 - 12 hours after the run"
Secondary	Observation of changes in hematocrit induced by a 100 km 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).	Day "15 - the run" and day "16 - 12 hours after the run"
Secondary	Observation of changes in erythropoietin level induced by a 100 km 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).	Day "15 - the run" and day "16 - 12 hours after the run"
Secondary	Observation of changes in erythroferrone level induced by a 100 km 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).	Day "15 - the run" and day "16 - 12 hours after the run"