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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05880030
Other study ID # AWFiS/2022_2_MK
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 19, 2016
Est. completion date December 31, 2022

Study information

Verified date November 2022
Source Gdansk University of Physical Education and Sport
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 31, 2022
Est. primary completion date November 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 28 Years to 64 Years
Eligibility 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 Design


Intervention

Drug:
Cholecalciferol
cholecalciferol 10000 UI
Other:
placebo
sunflower oil

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Gdansk University of Physical Education and Sport

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary The change in parathyroid hormone level after two-week supplementation. Measured parameter: parathyroid hormone [pg/ml]. Day 0 to day 14
Primary 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"
Primary 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"
Primary 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"
Primary 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 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"
Secondary 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"
Secondary 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"
Secondary 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"
Secondary 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"
Secondary 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"
Secondary 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"
Secondary 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"
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