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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Inflammation; Muscle, Iron Metabolism, Ineffective Erythropoiesis, Healthy

Intervention / Treatment
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* Drug: Cholecalciferol
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 28 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin D<br>Vigantol 10 000 IU/day (20 droplets) two weeks supplementation (vitamin D3) | Drug: Cholecalciferol<br>* cholecalciferol 10000 UI<br>* Other names: Vitamin D3;|
| Placebo Comparator: Control<br>sunflower oil, (20 droplets) two weeks supplementation. | Other: placebo<br>* sunflower oil<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| The change in parathyroid hormone level after two-week supplementation. | Measured parameter: parathyroid hormone [pg/ml]. | Day 0 to day 14 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, Running, inflammations, erythropoietin, iron, hepcidin