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

Sponsor

Gdansk University of Physical Education and Sport (Other)

Overall Status

Completed

CT.gov ID

NCT05880030

Collaborator

(none)

Enrollment

Arms

74.4

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammation; Muscle Iron Metabolism Ineffective Erythropoiesis Healthy	Drug: Cholecalciferol Other: placebo	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Oct 19, 2016

Actual Primary Completion Date :

Nov 1, 2022

Actual Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Vitamin D Vigantol 10 000 IU/day (20 droplets) two weeks supplementation (vitamin D3)	Drug: Cholecalciferol cholecalciferol 10000 UI Other Names: Vitamin D3
Placebo Comparator: Control sunflower oil, (20 droplets) two weeks supplementation.	Other: placebo sunflower oil

Arm

Intervention/Treatment

Active Comparator: Vitamin D

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

Drug: Cholecalciferol

cholecalciferol 10000 UI

Other Names:

Vitamin D3

Placebo Comparator: Control

sunflower oil, (20 droplets) two weeks supplementation.

Other: placebo

sunflower oil

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 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).
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 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).