ClinicalTrials.gg
CompletedNCT03417700Updated May 11, 2021

Vitamin D as a Factor Modifying Adaptation to Exercise

An interventional study of NW training and Placebo in Vitamin D3 Deficiency, sponsored by Gdansk University of Physical Education and Sport. Completed at 2 sites in Poland. Open to participants aged 15 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-11.

Sponsored by Gdansk University of Physical Education and Sport · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
15 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 64 studies in Motor Activity with a site in Poland — 17 open to participants now, 24 under way, none of them phase 3. Motor Activity · Poland.

Enrollment
23rd of 47
100 · median 100
Started
2018
with 5 others
No phase
41 of 64
13 open now
Registered
12th of 64
by date
Lead sponsor
5 of 64
Gdansk University of Physical Education and Sport

Among the 64 studies in Motor Activity with a site in Poland, this one is the 23rd largest by enrollment of the 47 interventional ones that give a count, is one of 6 that started in 2018, is one of 41 with no phase, and was the 12th registered.

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

Browse Motor Activity studies →

Open to participants now

17 of the 64 studies in Motor Activity with a site in Poland are open now. Recruiting first, the newest first:

12 more — sign in →

All 17 open studies →

A study can be open while its sites in Poland have not opened yet or have stopped. Only those recruiting at a site in Poland →

Who these studies take

Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.

This study: 15 Years to 80 Years · all sexes · healthy volunteers too.

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02

Study summary

Physical activity is a recommended, indispensable element of a healthy lifestyle as well as a countermeasure against many diseases often accompanied by the acute or chronic low grade inflammation. Papers published in recent years have demonstrated the anti-inflammatory effect of exercise. Based on current knowledge of the topic, own experience and preliminary work, it is expected the proposed research to provide information on the mechanism either determining or limiting pro-healthy effects of exercise in different age groups of people. Three different training programmes will be investigated. Specific goals of the project include the following:

  1. Establish, whether regular Nordic Walking training and HIIT can reduce the low-grade systemic inflammation and which type of training is the most effective at doing so.
  2. Establish, whether regular training can prevent muscle sarcopenia and assess if those changes are related to the concentration of the autophagy-inducing stress protein, HMGB1.
  3. Establish, whether regular Nordic Walking training alters iron metabolism and evaluate its correlation with the inflammatory markers and bone-morphogenesis.
  4. Establish, whether muscle-released irisin signals growth in the BDNF concentration in response to exercise and if these changes improve cognitive function.
  5. Establish, whether Nordic Walking or HIIT training effectively improve the blood lipid profile and aerobic capacity, and if these effects correlate with the blood 25-OHD concentration.
  6. Establish, whether concentration of vitamin D alters adaptation to training and modifies immunological response to regular training process.
Read the detailed description

The mechanism behind the anti-inflammatory effect of exercise is not fully understood. In some cases physical activity has proven almost/completely ineffective in reducing systemic inflammation. Thus, evaluating factors, which modify this response, is of particular significance. One of them may be related to iron metabolism. It is has been suggested that regular training reduces body iron stores, which can contribute to the anti-inflammatory response. Consequently, one of the anti-inflammatory effects of exercise can be related to changes in iron metabolism. Nevertheless, our preliminary data demonstrated that eight months of Nordic Walking training did not reduce body iron stores in approx. 25% of subjects, even if some of them were characterized by high blood ferritin (good indicator of body iron stores). This may be related to the effect of exercise on the concentration of hepcidin (main regulator of iron absorption, which acts as a negative regulator of iron efflux). It is well documented that a single bout of exercise induces an increase in blood hepcidin; however, data on the effect of regular training on the hepcidin concentration are limited.

Vitamin D is another factor, which could influence the anti-inflammatory effect of exercise. It has been suggested that individuals involved in physical activity have higher concentrations of 25OHD (indicator of vitamin D status). Vitamin D inhibits the expression of pro-inflammatory cytokines, which is considered the main mechanism of its anti-inflammatory action. It is worth noting that population in Poland is characterized by low status of vitamin D. Thus, it is possible that the anti-inflammatory effect of exercise will be modified by the vitamin status. Moreover, vitamin D has been shown to protect against muscle atrophy both in elderly and younger people. Its concentration has been correlated with muscle strength.

Inflammation has been observed to be associated with an increase of the autophagy-inducing stress protein, HMGB1, which mediates muscle atrophy. Measurement of plasma amino acid profile will be helpful to assess the impact of exercise on muscle proteolysis. Moreover, the link between exercise, vitamin D status and HMGB1 has not yet been established. In addition, a range of interactions induced by exercise involves the release of the newly discovered protein, irisin, form the muscle and its improving effect on the cognitive function through the synthesis of brain-derived neurotrophic factor (BDNF). Data on the effect of regular training on irisin concentration in elderly people is lacking.

Overall, our research interest focuses on the role of the factors mediating the anti-inflammatory effect of exercise and the way they stimulate or inhibit adaptive changes. The proposed project draws on our long experience in investigating the effects of exercise on iron metabolism as well as other physical methods supporting the anti-inflammatory action of physical activity. Latest published papers indicate that the concentration of vitamin D, also in training adaptation, can modulate immunological response to exercise. Therefore, verifying our hypothesis would also allow us to determine if the concentration of vitamin D can limit adaptation to physical activity.

03

Conditions studied

  • Vitamin D3 Deficiency

Browse trials for

Keywords

  • vitamin D
  • exercise
  • training
  • aging
04

Who can participate

Ages eligible
15 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

no illness medical check

Exclusion criteria

Exclusion Criteria:

uncontrolled hypertension (diastolic blood pressure over 100 mmHg), a history of cardiac arrhythmia, cardio-respiratory disorders, advanced osteoporosis, clinical diagnosis of Alzheimer's Disease

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Single (Investigator)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Training NW

    exercise and supplementation

    Dietary Supplement: NW training · Dietary Supplement: Placebo

  • Experimental
    Training HICT and vitamin D

    Training HICT plus vitamin D

    Dietary Supplement: NW training · Dietary Supplement: Placebo · Dietary Supplement: HICT

  • Experimental
    Placebo

    placebo Vitamin D

    Dietary Supplement: NW training

Interventions

  • Dietary supplementNW training

    NW training

    Also known as: Training, vitamin D

  • Dietary supplementPlacebo

    training with placebo

    Also known as: Control group

  • Dietary supplementHICT

    Training and vitamin D

    Also known as: resistance training

06

What researchers measure

Primary outcomes

  1. The influence of vitamin D on physical performance in aging people

    To verify if training supported by vitamin D supplementation will bring better effects

    Time frame: Values at baseline will be compared to values recorded 12 weeks and 3 months after the training programme.

07

Study locations

2 sites
  • University of Physical Education and Sport
    Gdansk, Pomorskie 80-336, Poland
  • Ziemann Ewa
    Sopot, Pomorskie 81-735, Poland
08

References and documents

Publications

  • Gmiat A, Mieszkowski J, Prusik K, Prusik K, Kortas J, Kochanowicz A, Radulska A, Lipinski M, Tomczyk M, Jaworska J, Antosiewicz J, Ziemann E. Changes in pro-inflammatory markers and leucine concentrations in response to Nordic Walking training combined with vitamin D supplementation in elderly women. Biogerontology. 2017 Aug;18(4):535-548. doi: 10.1007/s10522-017-9694-8. Epub 2017 Mar 18. PubMed 28316011 ↗
  • Prusik K, Kortas J, Prusik K, Mieszkowski J, Jaworska J, Skrobot W, Lipinski M, Ziemann E, Antosiewicz J. Nordic Walking Training Causes a Decrease in Blood Cholesterol in Elderly Women Supplemented with Vitamin D. Front Endocrinol (Lausanne). 2018 Feb 20;9:42. doi: 10.3389/fendo.2018.00042. eCollection 2018. PubMed 29515518 ↗
  • Walentukiewicz A, Lysak-Radomska A, Jaworska J, Prusik K, Prusik K, Kortas JA, Lipinski M, Babinska A, Antosiewicz J, Ziemann E. Vitamin D Supplementation and Nordic Walking Training Decreases Serum Homocysteine and Ferritin in Elderly Women. Int J Environ Res Public Health. 2018 Sep 20;15(10):2064. doi: 10.3390/ijerph15102064. PubMed 30241318 ↗
  • Mieszkowski J, Niespodzinski B, Kochanowicz A, Gmiat A, Prusik K, Prusik K, Kortas J, Ziemann E, Antosiewicz J. The Effect of Nordic Walking Training Combined with Vitamin D Supplementation on Postural Control and Muscle Strength in Elderly People-A Randomized Controlled Trial. Int J Environ Res Public Health. 2018 Sep 7;15(9):1951. doi: 10.3390/ijerph15091951. PubMed 30205445 ↗
  • Gmiat A, Jaworska J, Micielska K, Kortas J, Prusik K, Prusik K, Lipowski M, Radulska A, Szupryczynska N, Antosiewicz J, Ziemann E. Improvement of cognitive functions in response to a regular Nordic walking training in elderly women - A change dependent on the training experience. Exp Gerontol. 2018 Apr;104:105-112. doi: 10.1016/j.exger.2018.02.006. Epub 2018 Feb 9. PubMed 29432893 ↗
  • Kortas J, Kuchta A, Prusik K, Prusik K, Ziemann E, Labudda S, Cwiklinska A, Wieczorek E, Jankowski M, Antosiewicz J. Nordic walking training attenuation of oxidative stress in association with a drop in body iron stores in elderly women. Biogerontology. 2017 Aug;18(4):517-524. doi: 10.1007/s10522-017-9681-0. Epub 2017 Feb 22. PubMed 28229255 ↗

Individual participant data

Plan to share: No — Written-up results of research will be submitted for publication to international journals.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2018 to primary completion in Jan 2020, 23 months.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 23 months is above that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 30, 2017
First posted
Jan 31, 2018
StartActual
Jan 5, 2018
Primary completionActual
Jan 1, 2020
CompletionActual
Jan 10, 2020
Last update
May 11, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03417700
Lead sponsor
Gdansk University of Physical Education and Sport
Responsible party
Robert Olek (Associate Professor, Gdansk University of Physical Education and Sport) — Principal investigator
First posted
Jan 31, 2018
Start date
Jan 5, 2018
Primary completion
Jan 1, 2020
Completion
Jan 10, 2020
Last update
May 11, 2021

Study contacts

Ewa Ziemann
principal investigator · Gdansk University of Physical Education and Sport, Poland

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Vitamin D

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