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

Completed

Conditions

Healthy

Intervention / Treatment

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

Interventional

Enrollment (Actual)

Phase

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

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

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Taipei Medical University

Collaborators

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)

January 20, 2021

Primary Completion (Actual)

December 8, 2021

Study Completion (Actual)

December 8, 2021

Study Registration Dates

First Submitted

February 20, 2023

First Submitted That Met QC Criteria

March 9, 2023

First Posted (Actual)

March 22, 2023

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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

Studies a U.S. FDA-regulated device product

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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Vitamin D in Healthy Adults After Strenuous Endurance Exercise

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

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Healthy

Clinical Trials on Vitamin D

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