Vitamin D in Healthy Adults After Strenuous Endurance Exercise

Sponsor
Taipei Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT05779410
Collaborator
Panion & BF Biotech Inc. (Industry)
35
1
2
10.6
3.3

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Vitamin D
  • Dietary Supplement: Medium-chain triglycerides
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
35 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Healthy male participants were divided into vitamin D group and placebo group.Healthy male participants were divided into vitamin D group and placebo group.
Masking:
Double (Participant, Investigator)
Masking Description:
A double-blind, matched-pair study design
Primary Purpose:
Treatment
Official Title:
Effects of Vitamin D Supplementation on Biochemical Responses and Aerobic Capacity After Strenuous Endurance Exercise
Actual Study Start Date :
Jan 20, 2021
Actual Primary Completion Date :
Dec 8, 2021
Actual Study Completion Date :
Dec 8, 2021

Arms and Interventions

Arm Intervention/Treatment
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
  • 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

    Outcome Measures

    Primary Outcome Measures

    1. Concentration of Neutrophil [before exercise]

    2. Concentration ofNeutrophil [immediately after exercise]

    3. Concentration of Neutrophil [2-hour after exercise]

    4. Concentration of Neutrophil [4-hour after exercise]

    5. Concentration of Neutrophil [8-hour after exercise]

    6. Concentration of Neutrophil [24-hour after exercise]

    7. Concentration of eosinophil [before exercise]

    8. Concentration of eosinophil [immediately after exercise]

    9. Concentration of eosinophil [2-hour after exercise]

    10. Concentration of eosinophil [4-hour after exercise]

    11. Concentration of eosinophil [8-hour after exercise]

    12. Concentration of eosinophil [24-hour after exercise]

    13. Concentration of basophil [before exercise]

    14. Concentration of basophil [immediately after exercise]

    15. Concentration of basophil [2-hour after exercise]

    16. Concentration of basophil [4-hour after exercise]

    17. Concentration of basophil [8-hour after exercise]

    18. Concentration of basophil [24-hour after exercise]

    19. Concentration of monocyte [before exercise]

    20. Concentration of monocyte [immediately after exercise]

    21. Concentration of monocyte [2-hour after exercise]

    22. Concentration of monocyte [4-hour after exercise]

    23. Concentration of monocyte [8-hour after exercise]

    24. Concentration of monocyte [24-hour after exercise]

    25. Concentration of lymphocyte [before exercise]

    26. Concentration of lymphocyte [immediately after exercise]

    27. Concentration of lymphocyte [2-hour after exercise]

    28. Concentration of lymphocyte [4-hour after exercise]

    29. Concentration of lymphocyte [8-hour after exercise]

    30. Concentration of lymphocyte [24-hour after exercise]

    31. Concentration of CD4+ [before exercise]

    32. Concentration of CD4+ [immediately after exercise]

    33. Concentration of CD4+ [2-hour after exercise]

    34. Concentration of CD4+ [4-hour after exercise]

    35. Concentration of CD4+ [8-hour after exercise]

    36. Concentration of CD4+ [24-hour after exercise]

    37. Concentration of CD8+ [before exercise]

    38. Concentration of CD8+ [immediately after exercise]

    39. Concentration of CD8+ [2-hour after exercise]

    40. Concentration of CD8+ [4-hour after exercise]

    41. Concentration of CD8+ [8-hour after exercise]

    42. Concentration of CD8+ [24-hour after exercise]

    43. Concentration of CD19+ [before exercise]

    44. Concentration of CD19+ [immediately after exercise]

    45. Concentration of CD19+ [2-hour after exercise]

    46. Concentration of CD19+ [4-hour after exercise]

    47. Concentration of CD19+ [8-hour after exercise]

    48. Concentration of CD19+ [24-hour after exercise]

    49. Concentration of CD56+ [before exercise]

    50. Concentration of CD56+ [immediately after exercise]

    51. Concentration of CD56+ [2-hour after exercise]

    52. Concentration of CD56+ [4-hour after exercise]

    53. Concentration of CD56+ [8-hour after exercise]

    54. Concentration of CD56+ [24-hour after exercise]

    55. Concentration of IgA [before exercise]

    56. Concentration of IgA [immediately after exercise]

    57. Concentration of IgA [2-hour after exercise]

    58. Concentration of IgA [4-hour after exercise]

    59. Concentration of IgA [8-hour after exercise]

    60. Concentration of IgA [24-hour after exercise]

    61. Concentration of Cathelicidin [before exercise]

    62. Concentration of Cathelicidin [immediately after exercise]

    63. Concentration of Cathelicidin [2-hour after exercise]

    64. Concentration of Cathelicidin [4-hour after exercise]

    65. Concentration of Cathelicidin [8-hour after exercise]

    66. Concentration of Cathelicidin [24-hour after exercise]

    67. Concentration of TNF-α [before exercise]

    68. Concentration of TNF-α [immediately after exercise]

    69. Concentration of TNF-α [2-hour after exercise]

    70. Concentration of TNF-α [4-hour after exercise]

    71. Concentration of TNF-α [8-hour after exercise]

    72. Concentration of TNF-α [24-hour after exercise]

    73. Concentration of IL-1β [before exercise]

    74. Concentration of IL-1β [immediately after exercise]

    75. Concentration of IL-1β [2-hour after exercise]

    76. Concentration of IL-1β [4-hour after exercise]

    77. Concentration of IL-1β [8-hour after exercise]

    78. Concentration of IL-1β [24-hour after exercise]

    79. Concentration of IFN-γ [before exercise]

    80. Concentration of IFN-γ [immediately after exercise]

    81. Concentration of IFN-γ [2-hour after exercise]

    82. Concentration of IFN-γ [4-hour after exercise]

    83. Concentration of IFN-γ [8-hour after exercise]

    84. Concentration of IFN-γ [24-hour after exercise]

    85. Concentration of IL-2 [before exercise]

    86. Concentration of IL-2 [immediately after exercise]

    87. Concentration of IL-2 [2-hour after exercise]

    88. Concentration of IL-2 [4-hour after exercise]

    89. Concentration of IL-2 [8-hour after exercise]

    90. Concentration of IL-2 [24-hour after exercise]

    91. Concentration of IL-4 [before exercise]

    92. Concentration of IL-4 [immediately after exercise]

    93. Concentration of IL-4 [2-hour after exercise]

    94. Concentration of IL-4 [4-hour after exercise]

    95. Concentration of IL-4 [8-hour after exercise]

    96. Concentration of IL-4 [24-hour after exercise]

    97. Concentration of IL-8 [before exercise]

    98. Concentration of IL-8 [immediately after exercise]

    99. Concentration of IL-8 [2-hour after exercise]

    100. Concentration of IL-8 [4-hour after exercise]

    101. Concentration of IL-8 [8-hour after exercise]

    102. Concentration of IL-8 [24-hour after exercise]

    103. Concentration of IL-10 [before exercise]

    104. Concentration of IL-10 [immediately after exercise]

    105. Concentration of IL-10 [2-hour after exercise]

    106. Concentration of IL-10 [4-hour after exercise]

    107. Concentration of IL-10 [8-hour after exercise]

    108. Concentration of IL-10 [24-hour after exercise]

    109. Concentration of TBARS [before exercise]

    110. Concentration of TBARS [immediately after exercise]

    111. Concentration of TBARS [2-hour after exercise]

    112. Concentration of TBARS [4-hour after exercise]

    113. Concentration of TBARS [8-hour after exercise]

    114. Concentration of TBARS [24-hour after exercise]

    115. Concentration of PC [before exercise]

    116. Concentration of PC [immediately after exercise]

    117. Concentration of PC [2-hour after exercise]

    118. Concentration of PC [4-hour after exercise]

    119. Concentration of PC [8-hour after exercise]

    120. Concentration of PC [24-hour after exercise]

    121. Concentration of SOD [before exercise]

    122. Concentration of SOD [immediately after exercise]

    123. Concentration of SOD [2-hour after exercise]

    124. Concentration of SOD [4-hour after exercise]

    125. Concentration of SOD [8-hour after exercise]

    126. Concentration of SOD [24-hour after exercise]

    127. Concentration of catalase [before exercise]

    128. Concentration of catalase [immediately after exercise]

    129. Concentration of catalase [2-hour after exercise]

    130. Concentration of catalase [4-hour after exercise]

    131. Concentration of catalase [8-hour after exercise]

    132. Concentration of catalase [24-hour after exercise]

    133. Concentration of GPx [before exercise]

    134. Concentration of GPx [immediately after exercise]

    135. Concentration of GPx [2-hour after exercise]

    136. Concentration of GPx [4-hour after exercise]

    137. Concentration of GPx [8-hour after exercise]

    138. Concentration of GPx [24-hour after exercise]

    139. Concentration of CK [before exercise]

    140. Concentration of CK [immediately after exercise]

    141. Concentration of CK [2-hour after exercise]

    142. Concentration of CK [4-hour after exercise]

    143. Concentration of CK [8-hour after exercise]

    144. Concentration of CK [24-hour after exercise]

    145. Concentration of LDH [before exercise]

    146. Concentration of LDH [immediately after exercise]

    147. Concentration of LDH [2-hour after exercise]

    148. Concentration of LDH [4-hour after exercise]

    149. Concentration of LDH [8-hour after exercise]

    150. Concentration of LDH [24-hour after exercise]

    151. Concentration of IL-6 [before exercise]

    152. Concentration of IL-6 [immediately after exercise]

    153. Concentration of IL-6 [2-hour after exercise]

    154. Concentration of IL-6 [4-hour after exercise]

    155. Concentration of IL-6 [8-hour after exercise]

    156. Concentration of IL-6 [24-hour after exercise]

    157. Concentration of CRP [before exercise]

    158. Concentration of CRP [immediately after exercise]

    159. Concentration of CRP [2-hour after exercise]

    160. Concentration of CRP [4-hour after exercise]

    161. Concentration of CRP [8-hour after exercise]

    162. Concentration of CRP [24-hour after exercise]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 40 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Taipei Medical University Taipei Taiwan 110

    Sponsors and Collaborators

    • Taipei Medical University
    • Panion & BF Biotech Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Taipei Medical University
    ClinicalTrials.gov Identifier:
    NCT05779410
    Other Study ID Numbers:
    • N202010026
    • A-107-077
    First Posted:
    Mar 22, 2023
    Last Update Posted:
    Mar 22, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 22, 2023