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

NCT ID: NCT05880030

Last Updated: 2023-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-19

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Inflammation; Muscle Iron Metabolism Ineffective Erythropoiesis Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors
Both groups took drops from the same dark bottles, 20 drops per day for two weeks.

Study Groups

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Vitamin D

Vigantol 10 000 IU/day (20 droplets) two weeks supplementation (vitamin D3)

Group Type ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type DRUG

cholecalciferol 10000 UI

Control

sunflower oil, (20 droplets) two weeks supplementation.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

sunflower oil

Interventions

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Cholecalciferol

cholecalciferol 10000 UI

Intervention Type DRUG

placebo

sunflower oil

Intervention Type OTHER

Other Intervention Names

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Vitamin D3

Eligibility Criteria

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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)
Minimum Eligible Age

28 Years

Maximum Eligible Age

64 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Gdansk University of Physical Education and Sport

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katarzyna Kasprowicz, PhD

Role: STUDY_CHAIR

Gdansk University of Physical Education and Sport

Other Identifiers

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AWFiS/2022_2_MK

Identifier Type: -

Identifier Source: org_study_id

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