Vitamin D in Healthy Adults After Strenuous Endurance Exercise

March 9, 2023 updated by: Taipei Medical University

Effects of Vitamin D Supplementation on Biochemical Responses and Aerobic Capacity After Strenuous Endurance Exercise

The purpose of this study was to investigate the effects of vitamin D supplementation on biochemical response and aerobic capacity after strenuous endurance exercise (SEE).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

All participants conducted a graded exercise test on an ergometric bicycle to determine the maximal oxygen consumption (VO2max) before and after supplementation, and the speed equivalent to 65% VO2max was conducted for a SEE test by ergometric bicycle for 2 hours, followed by increasing 100 RPM until exhaustion. Venous blood samples were drawn before, immediately after, 2-hour after, 4-hour after, 8-hour after, and 24-hour after the SEE test to determine the concentrations of biomarkers. Data was analyzed by Two-way mixed design ANOVA.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 110
        • Taipei Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • The volunteers included have conditions as stated below :

    1. no history of cardiovascular, liver, kidney and diabetes disease
    2. no acute sport injury
    3. male adult whose concentration of 25(OH)D is under 30 ng/mL, and maximal oxygen consumption is over 40 ml/kg/min
    4. did not participated in any clinical trials or research in the last 3 months before our experiment
    5. no supplements were taken during the experimental period
    6. were requested to maintain their regular daily life style and avoid alcohol intake

Exclusion Criteria:

  • The volunteers were excluded if they have the situation stated below:

    1. history of cardiovascular, liver, kidney and diabetes disease
    2. acute sport injury
    3. their concentration of 25(OH)D is over 30 ng/mL, or maximal oxygen consumption is under 40 ml/kg/min
    4. participated in any clinical trials or experimental research in the last 3 months before our experiment
    5. taking supplement during the experimental period
    6. did not maintain their regular eating habit or drink alcohol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo group
Dietary supplement: Medium-chain triglycerides
Participants received the same amount of placebo matching vitamin D orally twice daily for 4 weeks
Experimental: Vitamin D group
Dietary supplement: Vitamin D
Participants received 5,000 IU of vitamin D orally twice daily for 4 weeks
Other Names:
  • Liquid Shield Vitamin D3+E

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Concentration of lymphocyte
Time Frame: immediately after exercise
immediately after exercise
Concentration of lymphocyte
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of lymphocyte
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of lymphocyte
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of CD4+
Time Frame: before exercise
before exercise
Concentration of CD4+
Time Frame: immediately after exercise
immediately after exercise
Concentration of CD4+
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of CD4+
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of CD4+
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of CD8+
Time Frame: before exercise
before exercise
Concentration of CD8+
Time Frame: immediately after exercise
immediately after exercise
Concentration of CD8+
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of CD8+
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of CD8+
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of CD19+
Time Frame: before exercise
before exercise
Concentration of CD19+
Time Frame: immediately after exercise
immediately after exercise
Concentration of CD19+
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of CD19+
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of CD19+
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of CD56+
Time Frame: immediately after exercise
immediately after exercise
Concentration of CD56+
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of CD56+
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of CD56+
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of TNF-α
Time Frame: before exercise
before exercise
Concentration of TNF-α
Time Frame: immediately after exercise
immediately after exercise
Concentration of TNF-α
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of TNF-α
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of TNF-α
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of IL-1β
Time Frame: before exercise
before exercise
Concentration of IL-1β
Time Frame: immediately after exercise
immediately after exercise
Concentration of IL-1β
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of IL-1β
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of IL-1β
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of IFN-γ
Time Frame: before exercise
before exercise
Concentration of IFN-γ
Time Frame: immediately after exercise
immediately after exercise
Concentration of IFN-γ
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of IFN-γ
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of IFN-γ
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of IL-2
Time Frame: before exercise
before exercise
Concentration of IL-2
Time Frame: immediately after exercise
immediately after exercise
Concentration of IL-2
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of IL-2
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of IL-2
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of IL-4
Time Frame: before exercise
before exercise
Concentration of IL-4
Time Frame: immediately after exercise
immediately after exercise
Concentration of IL-4
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of IL-4
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of IL-4
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of IL-8
Time Frame: before exercise
before exercise
Concentration of IL-8
Time Frame: immediately after exercise
immediately after exercise
Concentration of IL-8
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of IL-8
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of IL-8
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of IL-10
Time Frame: before exercise
before exercise
Concentration of IL-10
Time Frame: immediately after exercise
immediately after exercise
Concentration of IL-10
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of IL-10
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of IL-10
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of TBARS
Time Frame: before exercise
before exercise
Concentration of TBARS
Time Frame: immediately after exercise
immediately after exercise
Concentration of TBARS
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of TBARS
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of TBARS
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of PC
Time Frame: before exercise
before exercise
Concentration of PC
Time Frame: immediately after exercise
immediately after exercise
Concentration of PC
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of PC
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of PC
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of SOD
Time Frame: before exercise
before exercise
Concentration of SOD
Time Frame: immediately after exercise
immediately after exercise
Concentration of SOD
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of SOD
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of SOD
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of catalase
Time Frame: before exercise
before exercise
Concentration of catalase
Time Frame: immediately after exercise
immediately after exercise
Concentration of catalase
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of catalase
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of catalase
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of GPx
Time Frame: before exercise
before exercise
Concentration of GPx
Time Frame: immediately after exercise
immediately after exercise
Concentration of GPx
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of GPx
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of GPx
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of CK
Time Frame: before exercise
before exercise
Concentration of CK
Time Frame: immediately after exercise
immediately after exercise
Concentration of CK
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of CK
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of CK
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of LDH
Time Frame: before exercise
before exercise
Concentration of LDH
Time Frame: immediately after exercise
immediately after exercise
Concentration of LDH
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of LDH
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of LDH
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of IL-6
Time Frame: before exercise
before exercise
Concentration of IL-6
Time Frame: immediately after exercise
immediately after exercise
Concentration of IL-6
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of IL-6
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of IL-6
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of Neutrophil
Time Frame: before exercise
before exercise
Concentration ofNeutrophil
Time Frame: immediately after exercise
immediately after exercise
Concentration of Neutrophil
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of Neutrophil
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of Neutrophil
Time Frame: 8-hour after exercise
8-hour after exercise
Concentration of Neutrophil
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of eosinophil
Time Frame: before exercise
before exercise
Concentration of eosinophil
Time Frame: immediately after exercise
immediately after exercise
Concentration of eosinophil
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of eosinophil
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of eosinophil
Time Frame: 8-hour after exercise
8-hour after exercise
Concentration of eosinophil
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of basophil
Time Frame: before exercise
before exercise
Concentration of basophil
Time Frame: immediately after exercise
immediately after exercise
Concentration of basophil
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of basophil
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of basophil
Time Frame: 8-hour after exercise
8-hour after exercise
Concentration of basophil
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of monocyte
Time Frame: before exercise
before exercise
Concentration of monocyte
Time Frame: immediately after exercise
immediately after exercise
Concentration of monocyte
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of monocyte
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of monocyte
Time Frame: 8-hour after exercise
8-hour after exercise
Concentration of monocyte
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of lymphocyte
Time Frame: before exercise
before exercise
Concentration of lymphocyte
Time Frame: 8-hour after exercise
8-hour after exercise
Concentration of CD4+
Time Frame: 8-hour after exercise
8-hour after exercise
Concentration of CD8+
Time Frame: 8-hour after exercise
8-hour after exercise
Concentration of CD19+
Time Frame: 8-hour after exercise
8-hour after exercise
Concentration of CD56+
Time Frame: before exercise
before exercise
Concentration of CD56+
Time Frame: 8-hour after exercise
8-hour after exercise
Concentration of IgA
Time Frame: before exercise
before exercise
Concentration of IgA
Time Frame: immediately after exercise
immediately after exercise
Concentration of IgA
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of IgA
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of IgA
Time Frame: 8-hour after exercise
8-hour after exercise
Concentration of IgA
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of Cathelicidin
Time Frame: before exercise
before exercise
Concentration of Cathelicidin
Time Frame: immediately after exercise
immediately after exercise
Concentration of Cathelicidin
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of Cathelicidin
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of Cathelicidin
Time Frame: 8-hour after exercise
8-hour after exercise
Concentration of Cathelicidin
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of TNF-α
Time Frame: 8-hour after exercise
8-hour after exercise
Concentration of IL-1β
Time Frame: 8-hour after exercise
8-hour after exercise
Concentration of IFN-γ
Time Frame: 8-hour after exercise
8-hour after exercise
Concentration of IL-2
Time Frame: 8-hour after exercise
8-hour after exercise
Concentration of IL-4
Time Frame: 8-hour after exercise
8-hour after exercise
Concentration of IL-8
Time Frame: 8-hour after exercise
8-hour after exercise
Concentration of IL-10
Time Frame: 8-hour after exercise
8-hour after exercise
Concentration of TBARS
Time Frame: 8-hour after exercise
8-hour after exercise
Concentration of PC
Time Frame: 8-hour after exercise
8-hour after exercise
Concentration of SOD
Time Frame: 8-hour after exercise
8-hour after exercise
Concentration of catalase
Time Frame: 8-hour after exercise
8-hour after exercise
Concentration of GPx
Time Frame: 8-hour after exercise
8-hour after exercise
Concentration of CK
Time Frame: 8-hour after exercise
8-hour after exercise
Concentration of LDH
Time Frame: 8-hour after exercise
8-hour after exercise
Concentration of IL-6
Time Frame: 8-hour after exercise
8-hour after exercise
Concentration of CRP
Time Frame: before exercise
before exercise
Concentration of CRP
Time Frame: immediately after exercise
immediately after exercise
Concentration of CRP
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of CRP
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of CRP
Time Frame: 8-hour after exercise
8-hour after exercise
Concentration of CRP
Time Frame: 24-hour after exercise
24-hour after exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taipei Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Panion & BF Biotech Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 8, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 8, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • N202010026
  • A-107-077 (Other Grant/Funding Number: Panion & BF Biotech Inc.)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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