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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Iron Metabolism; Ineffective Erythropoiesis; Inflammation; Muscle
• Intervention / Treatment: Drug: Cholecalciferol; Other: placebo

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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"

Collaborators and Investigators

• Sponsor: Gdansk University of Physical Education and Sport
• Investigators: Study Chair: Katarzyna Kasprowicz, PhD, Gdansk University of Physical Education and Sport

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2016
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: December 15, 2022
• First Submitted That Met QC Criteria: May 18, 2023
• First Posted (Actual): May 30, 2023

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 18, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Vitamin D; hepcidin; erythropoietin; Running; iron; inflammations
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Inflammation; Myositis; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: AWFiS/2022_2_MK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No