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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
Gdansk University of Physical Education and Sport
About
Eligibility
Locations
Arms
Outcomes
Full info

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

28 Years - 64 Years (Adult)MaleAccepts Healthy Volunteers

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

    First Posted
    December 15, 2022
    Last Updated
    May 18, 2023
    Sponsor
    Gdansk University of Physical Education and Sport
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    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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