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Inflammation; MuscleNCT05880030

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

A study testing Cholecalciferol in people with Inflammation; Muscle and Iron Metabolism, run by Gdansk University of Physical Education and Sport.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 28 to 64 years, men onlyHealthy volunteers can take part
What is being tested?
Cholecalciferol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
No sites listed yet
Study dates
19 Oct 2016to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 28 to 64 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • male
  • athletes running ultra-marathons

Who cannot join

  • 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)

About this study

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.

Read the 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.

Being tested
Cholecalciferol, placebo
Keywords
Vitamin D, Running, inflammations, erythropoietin, iron, hepcidin
Medical subject headings
Myositis, Inclusion Body, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CholecalciferolDrug

    Also called Vitamin D3

    cholecalciferol 10000 UI

  • placeboOther

    sunflower oil

Study groups in NCT05880030
Study groupRoleWhat they receive
Vitamin DActive comparatorVigantol 10 000 IU/day (20 droplets) two weeks supplementation (vitamin D3)
Receives: Drug: Cholecalciferol
ControlPlacebo comparatorsunflower oil, (20 droplets) two weeks supplementation.
Receives: Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The change in vitamin 25(OH)D level after two-week supplementation.

    Measured parameter: vitamin 25(OH)D [ng/ml].

    Measured: Day 0 to day 14

  2. The change in parathyroid hormone level after two-week supplementation.

    Measured parameter: parathyroid hormone [pg/ml].

    Measured: Day 0 to day 14

  3. 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).

    Measured: Day "15 - the run" and day "16 - 12 hours after the run"

  4. 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).

    Measured: Day "15 - the run" and day "16 - 12 hours after the run"

  5. 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).

    Measured: Day "15 - the run" and day "16 - 12 hours after the run"

  6. 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).

    Measured: Day "15 - the run" and day "16 - 12 hours after the run"

Secondary outcomes (8)

  1. 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).

    Measured: Day "15 - the run" and day "16 - 12 hours after the run"

  2. 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).

    Measured: Day "15 - the run" and day "16 - 12 hours after the run"

  3. 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).

    Measured: Day "15 - the run" and day "16 - 12 hours after the run"

  4. 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).

    Measured: Day "15 - the run" and day "16 - 12 hours after the run"

  5. 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).

    Measured: Day "15 - the run" and day "16 - 12 hours after the run"

  6. 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).

    Measured: Day "15 - the run" and day "16 - 12 hours after the run"

  7. 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).

    Measured: Day "15 - the run" and day "16 - 12 hours after the run"

  8. 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).

    Measured: Day "15 - the run" and day "16 - 12 hours after the run"

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2023
  2. Study start19 Oct 2016
  3. Primary completion1 Nov 2022
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05880030
Sponsor's protocol ID
AWFiS/2022_2_MK
Status last verified
Nov 2022
First submitted
15 Dec 2022
Last updated
30 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Cholecalciferol in people with Inflammation; Muscle and Iron Metabolism, run by Gdansk University of Physical Education and Sport.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change in vitamin 25(OH)D level after two-week supplementation. (time frame: Day 0 to day 14). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05880030.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2023.

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