Vitamin D Supplementation in Healthy Adults in Prolonged Endurance Exercise

December 18, 2023 updated by: Taipei Medical University

Effects of Vitamin D Supplementation on Biochemical Reaction and Skeletal Muscle Synthesis in Prolonged Endurance Exercise and Cluster Set Configurations of Resistance Training

The purpose of this study is to investigate the effects of vitamin D supplementation on biochemistry response and skeletal muscle synthesis in prolonged endurance exercise.

Study Overview

Status

Active, not recruiting

Conditions

Healthy

Intervention / Treatment

Detailed Description

Endurance exercise mode will be used to evaluate the effects of vitamin D supplementation on cardiac biomarkers, metabolic hormones, oxidative damage, and inflammation responses. An independent samples and dose titration design will be used to assign 30 participants to the experimental group (n = 15) or placebo group (n = 15). All participants in the experimental group will have serum 25(OH)D concentrations higher than 48 ng/mL after supplementation period. After the prolonged endurance exercise test, the blood samples will be collected for analyzing biomarkers. Data will be analyzed by Two-way mixed design ANOVA.

Study Type

Interventional

Enrollment (Estimated)

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

Description

Inclusion criteria:

The volunteers included have conditions as stated below :
1. male adult between 20-40 years old without any 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/mint
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.
Experimental: Vitamin D group	Dietary supplement: Vitamin D Participants received 5,000 IU of vitamin D orally twice daily for 4 weeks. If the serum 25(OH)D concentration exceeds 48 ng/mL, the intervention remains the same. However, if the serum 25(OH)D concentration is under 48 ng/mL, the dosage would increase by 2,500 IU. The principle remains the same at week 6.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Concentration of leukocyte Time Frame: before exercise	before exercise
Concentration of leukocyte Time Frame: immediately after exercise	immediately after exercise
Concentration of leukocyte Time Frame: 2-hour after exercise	2-hour after exercise
Concentration of leukocyte Time Frame: 24-hour after exercise	24-hour after exercise
Concentration of neutrophil Time Frame: before exercise	before exercise
Concentration of neutrophil 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: 24-hour after exercise	24-hour after exercise
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: 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: 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: 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: 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: 24-hour after exercise	24-hour after exercise
Concentration of CK-MB Time Frame: before exercise	before exercise
Concentration of CK-MB Time Frame: 2-hour after exercise	2-hour after exercise
Concentration of CK-MB Time Frame: 24-hour after exercise	24-hour after exercise
Concentration of CK-MB Time Frame: immediately after exercise	immediately 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: 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: 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: 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: 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: 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: 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: 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: 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: 24-hour after exercise	24-hour after exercise
Concentration of cTnI Time Frame: before exercise	before exercise
Concentration of cTnI Time Frame: immediately after exercise	immediately after exercise
Concentration of cTnI Time Frame: 2-hour after exercise	2-hour after exercise
Concentration of cTnI 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: 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: 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: 24-hour after exercise	24-hour after exercise
Concentration of lymphocyte Time Frame: before exercise	before exercise
Concentration of CD56+ Time Frame: before exercise	before exercise
Concentration of NT-proBNP Time Frame: before exercise	before exercise
Concentration of NT-proBNP Time Frame: immediately after exercise	immediately after exercise
Concentration of NT-proBNP Time Frame: 2-hour after exercise	2-hour after exercise
Concentration of NT-proBNP Time Frame: 24-hour after exercise	24-hour after exercise
Concentration of Testosterone Time Frame: before exercise	before exercise
Concentration of Testosterone Time Frame: immediately after exercise	immediately after exercise
Concentration of Testosterone Time Frame: 2-hour after exercise	2-hour after exercise
Concentration of Testosterone Time Frame: 24-hour after exercise	24-hour after exercise
Concentration of Cortisol Time Frame: before exercise	before exercise
Concentration of Cortisol Time Frame: immediately after exercise	immediately after exercise
Concentration of Cortisol Time Frame: 2-hour after exercise	2-hour after exercise
Concentration of Cortisol Time Frame: 24-hour after exercise	24-hour after exercise
Concentration of β-endorphin Time Frame: before exercise	before exercise
Concentration of β-endorphin Time Frame: immediately after exercise	immediately after exercise
Concentration of β-endorphin Time Frame: 2-hour after exercise	2-hour after exercise
Concentration of β-endorphin Time Frame: 24-hour after exercise	24-hour after exercise
Concentration of Growth hormone Time Frame: before exercise	before exercise
Concentration of Growth hormone Time Frame: immediately after exercise	immediately after exercise
Concentration of Growth hormone Time Frame: 2-hour after exercise	2-hour after exercise
Concentration of Growth hormone Time Frame: 24-hour after exercise	24-hour after exercise
Concentration of IGF-1 Time Frame: before exercise	before exercise
Concentration of IGF-1 Time Frame: immediately after exercise	immediately after exercise
Concentration of IGF-1 Time Frame: 2-hour after exercise	2-hour after exercise
Concentration of IGF-1 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: 24-hour after exercise	24-hour after exercise
Concentration of IL-15 Time Frame: before exercise	before exercise
Concentration of IL-15 Time Frame: immediately after exercise	immediately after exercise
Concentration of IL-15 Time Frame: 2-hour after exercise	2-hour after exercise
Concentration of IL-15 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)

October 21, 2022

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

February 1, 2024

Study Registration Dates

First Submitted

February 20, 2023

First Submitted That Met QC Criteria

March 10, 2023

First Posted (Actual)

March 23, 2023

Study Record Updates

Last Update Posted (Estimated)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 18, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

N202205045
NSTC111-2410-H-038 -015 (Other Grant/Funding Number: National Science and Technology Council)

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 Supplementation in Healthy Adults in Prolonged Endurance Exercise

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

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 (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Estimated)

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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Drug Interventions

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Conditions

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