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HealthyNCT05781620

Vitamin D Supplementation in Healthy Adults in Prolonged Endurance Exercise

A study testing Vitamin D and Medium-chain triglycerides in people with Healthy, run by Taipei Medical University at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Vitamin D and Medium-chain triglycerides
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteTaiwan
Study dates
21 Oct 2022to Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • The volunteers included have conditions as stated below :
  • male adult between 20-40 years old without any history of cardiovascular, liver, kidney and diabetes disease
  • no acute sport injury
  • male adult whose concentration of 25(OH)D is under 30 ng/mL, and maximal oxygen consumption is over 40 ml/kg/min
  • did not participated in any clinical trials or research in the last 3 months before our experiment
  • no supplements were taken during the experimental period
  • were requested to maintain their regular daily life style and avoid alcohol intake

Who cannot join

  • The volunteers were excluded if they have the situation stated below:
  • history of cardiovascular, liver, kidney and diabetes disease
  • acute sport injury
  • their concentration of 25(OH)D is over 30 ng/mL, or maximal oxygen consumption is under 40 ml/kg/mint
  • participated in any clinical trials or experimental research in the last 3 months before our experiment
  • taking supplement during the experimental period
  • did not maintain their regular eating habit or drink alcohol

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Taipei Medical University

    Taipei, 110

Other trials in Taiwan

About this study

Official title: 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.

Read the 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.

Conditions
Healthy
Being tested
Vitamin D, Medium-chain triglycerides

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin DDietary supplement

    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.

  • Medium-chain triglyceridesDietary supplement

    Participants received the same amount of placebo matching vitamin D orally twice daily.

Study groups in NCT05781620
Study groupRoleWhat they receive
Vitamin D groupExperimentalNot described
Receives: Dietary Supplement: Vitamin D
Placebo groupPlacebo comparatorNot described
Receives: Dietary Supplement: Medium-chain triglycerides

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Concentration of NT-proBNP

    Measured: before exercise

  2. Concentration of NT-proBNP

    Measured: immediately after exercise

  3. Concentration of NT-proBNP

    Measured: 2-hour after exercise

  4. Concentration of NT-proBNP

    Measured: 24-hour after exercise

  5. Concentration of cTnI

    Measured: before exercise

  6. Concentration of cTnI

    Measured: immediately after exercise

  7. Concentration of cTnI

    Measured: 2-hour after exercise

  8. Concentration of cTnI

    Measured: 24-hour after exercise

  9. Concentration of CK-MB

    Measured: before exercise

  10. Concentration of CK-MB

    Measured: immediately after exercise

  11. Concentration of CK-MB

    Measured: 2-hour after exercise

  12. Concentration of CK-MB

    Measured: 24-hour after exercise

  13. Concentration of CK

    Measured: before exercise

  14. Concentration of CK

    Measured: immediately after exercise

  15. Concentration of CK

    Measured: 2-hour after exercise

  16. Concentration of CK

    Measured: 24-hour after exercise

  17. Concentration of Testosterone

    Measured: before exercise

  18. Concentration of Testosterone

    Measured: immediately after exercise

  19. Concentration of Testosterone

    Measured: 2-hour after exercise

  20. Concentration of Testosterone

    Measured: 24-hour after exercise

  21. Concentration of Cortisol

    Measured: before exercise

  22. Concentration of Cortisol

    Measured: immediately after exercise

  23. Concentration of Cortisol

    Measured: 2-hour after exercise

  24. Concentration of Cortisol

    Measured: 24-hour after exercise

  25. Concentration of β-endorphin

    Measured: before exercise

  26. Concentration of β-endorphin

    Measured: immediately after exercise

  27. Concentration of β-endorphin

    Measured: 2-hour after exercise

  28. Concentration of β-endorphin

    Measured: 24-hour after exercise

  29. Concentration of Growth hormone

    Measured: before exercise

  30. Concentration of Growth hormone

    Measured: immediately after exercise

  31. Concentration of Growth hormone

    Measured: 2-hour after exercise

  32. Concentration of Growth hormone

    Measured: 24-hour after exercise

  33. Concentration of IGF-1

    Measured: before exercise

  34. Concentration of IGF-1

    Measured: immediately after exercise

  35. Concentration of IGF-1

    Measured: 2-hour after exercise

  36. Concentration of IGF-1

    Measured: 24-hour after exercise

  37. Concentration of TBARS

    Measured: before exercise

  38. Concentration of TBARS

    Measured: immediately after exercise

  39. Concentration of TBARS

    Measured: 2-hour after exercise

  40. Concentration of TBARS

    Measured: 24-hour after exercise

  41. Concentration of PC

    Measured: before exercise

  42. Concentration of PC

    Measured: immediately after exercise

  43. Concentration of PC

    Measured: 2-hour after exercise

  44. Concentration of PC

    Measured: 24-hour after exercise

  45. Concentration of SOD

    Measured: before exercise

  46. Concentration of SOD

    Measured: immediately after exercise

  47. Concentration of SOD

    Measured: 2-hour after exercise

  48. Concentration of SOD

    Measured: 24-hour after exercise

  49. Concentration of Catalase

    Measured: before exercise

  50. Concentration of Catalase

    Measured: immediately after exercise

  51. Concentration of Catalase

    Measured: 2-hour after exercise

  52. Concentration of Catalase

    Measured: 24-hour after exercise

  53. Concentration of TNF-α

    Measured: before exercise

  54. Concentration of TNF-α

    Measured: immediately after exercise

  55. Concentration of TNF-α

    Measured: 2-hour after exercise

  56. Concentration of TNF-α

    Measured: 24-hour after exercise

  57. Concentration of IL-8

    Measured: before exercise

  58. Concentration of IL-8

    Measured: immediately after exercise

  59. Concentration of IL-8

    Measured: 2-hour after exercise

  60. Concentration of IL-8

    Measured: 24-hour after exercise

  61. Concentration of IL-10

    Measured: before exercise

  62. Concentration of IL-10

    Measured: immediately after exercise

  63. Concentration of IL-10

    Measured: 2-hour after exercise

  64. Concentration of IL-10

    Measured: 24-hour after exercise

  65. Concentration of LDH

    Measured: before exercise

  66. Concentration of LDH

    Measured: immediately after exercise

  67. Concentration of LDH

    Measured: 2-hour after exercise

  68. Concentration of LDH

    Measured: 24-hour after exercise

  69. Concentration of IL-6

    Measured: before exercise

  70. Concentration of IL-6

    Measured: immediately after exercise

  71. Concentration of IL-6

    Measured: 2-hour after exercise

  72. Concentration of IL-6

    Measured: 24-hour after exercise

  73. Concentration of IL-15

    Measured: before exercise

  74. Concentration of IL-15

    Measured: immediately after exercise

  75. Concentration of IL-15

    Measured: 2-hour after exercise

  76. Concentration of IL-15

    Measured: 24-hour after exercise

  77. Concentration of leukocyte

    Measured: before exercise

  78. Concentration of leukocyte

    Measured: immediately after exercise

  79. Concentration of leukocyte

    Measured: 2-hour after exercise

  80. Concentration of leukocyte

    Measured: 24-hour after exercise

  81. Concentration of neutrophil

    Measured: before exercise

  82. Concentration of neutrophil

    Measured: immediately after exercise

  83. Concentration of neutrophil

    Measured: 2-hour after exercise

  84. Concentration of neutrophil

    Measured: 24-hour after exercise

  85. Concentration of eosinophil

    Measured: before exercise

  86. Concentration of eosinophil

    Measured: immediately after exercise

  87. Concentration of eosinophil

    Measured: 2-hour after exercise

  88. Concentration of eosinophil

    Measured: 24-hour after exercise

  89. Concentration of basophil

    Measured: before exercise

  90. Concentration of basophil

    Measured: immediately after exercise

  91. Concentration of basophil

    Measured: 2-hour after exercise

  92. Concentration of basophil

    Measured: 24-hour after exercise

  93. Concentration of monocyte

    Measured: before exercise

  94. Concentration of monocyte

    Measured: immediately after exercise

  95. Concentration of monocyte

    Measured: 2-hour after exercise

  96. Concentration of monocyte

    Measured: 24-hour after exercise

  97. Concentration of lymphocyte

    Measured: before exercise

  98. Concentration of lymphocyte

    Measured: immediately after exercise

  99. Concentration of lymphocyte

    Measured: 2-hour after exercise

  100. Concentration of lymphocyte

    Measured: 24-hour after exercise

  101. Concentration of CD4+

    Measured: before exercise

  102. Concentration of CD4+

    Measured: immediately after exercise

  103. Concentration of CD4+

    Measured: 2-hour after exercise

  104. Concentration of CD4+

    Measured: 24-hour after exercise

  105. Concentration of CD8+

    Measured: before exercise

  106. Concentration of CD8+

    Measured: immediately after exercise

  107. Concentration of CD8+

    Measured: 2-hour after exercise

  108. Concentration of CD8+

    Measured: 24-hour after exercise

  109. Concentration of CD19+

    Measured: before exercise

  110. Concentration of CD19+

    Measured: immediately after exercise

  111. Concentration of CD19+

    Measured: 2-hour after exercise

  112. Concentration of CD19+

    Measured: 24-hour after exercise

  113. Concentration of CD56+

    Measured: before exercise

  114. Concentration of CD56+

    Measured: immediately after exercise

  115. Concentration of CD56+

    Measured: 2-hour after exercise

  116. Concentration of CD56+

    Measured: 24-hour after exercise

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2023
  2. Study start21 Oct 2022
  3. Primary completionFeb 2024 (estimated)
  4. Study completionFeb 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
An independent samples and dose titration design will be used to assign participants to the experimental group or placebo group.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05781620
Sponsor's protocol ID
N202205045
Other IDs
NSTC111-2410-H-038 -015
Status last verified
Feb 2023
First submitted
20 Feb 2023
Last updated
19 Dec 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Vitamin D and Medium-chain triglycerides in people with Healthy, run by Taipei Medical University at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concentration of NT-proBNP (time frame: before exercise). The study lists 116 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05781620.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.

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