The Effect of Supplementation of Vitamin D3 on Inflammation Induced by 100 km Running, Iron Metabolism and Erythropoiesis
Primary Purpose
Inflammation; Muscle, Iron Metabolism, Ineffective Erythropoiesis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cholecalciferol
placebo
Sponsored by
About this trial
This is an interventional basic science trial for Inflammation; Muscle focused on measuring Vitamin D, Running, inflammations, erythropoietin, iron, hepcidin
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Vitamin D
Control
Arm Description
Vigantol 10 000 IU/day (20 droplets) two weeks supplementation (vitamin D3)
sunflower oil, (20 droplets) two weeks supplementation.
Outcomes
Primary Outcome Measures
The change in vitamin 25(OH)D level after two-week supplementation.
Measured parameter: vitamin 25(OH)D [ng/ml].
The change in parathyroid hormone level after two-week supplementation.
Measured parameter: parathyroid hormone [pg/ml].
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).
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).
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).
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).
Secondary Outcome Measures
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).
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).
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).
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).
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).
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).
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).
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).
Full Information
NCT ID
NCT05880030
First Posted
December 15, 2022
Last Updated
May 18, 2023
Sponsor
Gdansk University of Physical Education and Sport
1. Study Identification
Unique Protocol Identification Number
NCT05880030
Brief Title
The Effect of Supplementation of Vitamin D3 on Inflammation Induced by 100 km Running, Iron Metabolism and Erythropoiesis
Official Title
The Effect of Supplementation of Vitamin D3 on Inflammation Induced by 100 km Running, Iron Metabolism and Erythropoiesis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 19, 2016 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gdansk University of Physical Education and Sport
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation; Muscle, Iron Metabolism, Ineffective Erythropoiesis, Healthy
Keywords
Vitamin D, Running, inflammations, erythropoietin, iron, hepcidin
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Both groups took drops from the same dark bottles, 20 drops per day for two weeks.
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D
Arm Type
Active Comparator
Arm Description
Vigantol 10 000 IU/day (20 droplets) two weeks supplementation (vitamin D3)
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
sunflower oil, (20 droplets) two weeks supplementation.
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
Vitamin D3
Intervention Description
cholecalciferol 10000 UI
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
sunflower oil
Primary Outcome Measure Information:
Title
The change in vitamin 25(OH)D level after two-week supplementation.
Description
Measured parameter: vitamin 25(OH)D [ng/ml].
Time Frame
Day 0 to day 14
Title
The change in parathyroid hormone level after two-week supplementation.
Description
Measured parameter: parathyroid hormone [pg/ml].
Time Frame
Day 0 to day 14
Title
Observation of changes in inflammatory parameters:interleukin-6 induced by a 100 km run
Description
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).
Time Frame
Day "15 - the run" and day "16 - 12 hours after the run"
Title
Observation of changes in inflammatory parameters: C reactive protein - CRP induced by 100 km running.
Description
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).
Time Frame
Day "15 - the run" and day "16 - 12 hours after the run"
Title
Observation of changes in creatine kinase level induced by 100 km running.
Description
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).
Time Frame
Day "15 - the run" and day "16 - 12 hours after the run"
Title
Observation of changes in leucocytes induced by 100 km running.
Description
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).
Time Frame
Day "15 - the run" and day "16 - 12 hours after the run"
Secondary Outcome Measure Information:
Title
Observation of changes in hepcidin level induced by 100 km running.
Description
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).
Time Frame
Day "15 - the run" and day "16 - 12 hours after the run"
Title
Observation of changes in serum iron level induced by 100 km running.
Description
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).
Time Frame
Day "15 - the run" and day "16 - 12 hours after the run"
Title
Observation of changes in ferritin induced by 100 km running.
Description
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).
Time Frame
Day "15 - the run" and day "16 - 12 hours after the run"
Title
Observation of changes in erythrocytes level induced by a 100 km run.
Description
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).
Time Frame
Day "15 - the run" and day "16 - 12 hours after the run"
Title
Observation of changes in reticulocytes induced by a 100 km run.
Description
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).
Time Frame
Day "15 - the run" and day "16 - 12 hours after the run"
Title
Observation of changes in hematocrit induced by a 100 km run.
Description
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).
Time Frame
Day "15 - the run" and day "16 - 12 hours after the run"
Title
Observation of changes in erythropoietin level induced by a 100 km run.
Description
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).
Time Frame
Day "15 - the run" and day "16 - 12 hours after the run"
Title
Observation of changes in erythroferrone level induced by a 100 km run.
Description
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).
Time Frame
Day "15 - the run" and day "16 - 12 hours after the run"
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
28 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katarzyna Kasprowicz, PhD
Organizational Affiliation
Gdansk University of Physical Education and Sport
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of Supplementation of Vitamin D3 on Inflammation Induced by 100 km Running, Iron Metabolism and Erythropoiesis
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