Vitamin D in Healthy Adults After Strenuous Endurance Exercise

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05779410
• Other study ID #: N202010026
• Secondary ID: A-107-077
• Status: Completed
• Phase: N/A
• Start date: January 20, 2021
• Est. completion date: December 8, 2021

Study information

• Verified date: February 2023
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 8, 2021
• Est. primary completion date: December 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Vitamin D
Participants received 5,000 IU of vitamin D orally twice daily for 4 weeks
• Medium-chain triglycerides
Participants received the same amount of placebo matching vitamin D orally twice daily for 4 weeks

Locations

Country	Name	City	State
Taiwan	Taipei Medical University	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Medical University	Panion & BF Biotech Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of Neutrophil		before exercise
Primary	Concentration ofNeutrophil		immediately after exercise
Primary	Concentration of Neutrophil		2-hour after exercise
Primary	Concentration of Neutrophil		4-hour after exercise
Primary	Concentration of Neutrophil		8-hour after exercise
Primary	Concentration of Neutrophil		24-hour after exercise
Primary	Concentration of eosinophil		before exercise
Primary	Concentration of eosinophil		immediately after exercise
Primary	Concentration of eosinophil		2-hour after exercise
Primary	Concentration of eosinophil		4-hour after exercise
Primary	Concentration of eosinophil		8-hour after exercise
Primary	Concentration of eosinophil		24-hour after exercise
Primary	Concentration of basophil		before exercise
Primary	Concentration of basophil		immediately after exercise
Primary	Concentration of basophil		2-hour after exercise
Primary	Concentration of basophil		4-hour after exercise
Primary	Concentration of basophil		8-hour after exercise
Primary	Concentration of basophil		24-hour after exercise
Primary	Concentration of monocyte		before exercise
Primary	Concentration of monocyte		immediately after exercise
Primary	Concentration of monocyte		2-hour after exercise
Primary	Concentration of monocyte		4-hour after exercise
Primary	Concentration of monocyte		8-hour after exercise
Primary	Concentration of monocyte		24-hour after exercise
Primary	Concentration of lymphocyte		before exercise
Primary	Concentration of lymphocyte		immediately after exercise
Primary	Concentration of lymphocyte		2-hour after exercise
Primary	Concentration of lymphocyte		4-hour after exercise
Primary	Concentration of lymphocyte		8-hour after exercise
Primary	Concentration of lymphocyte		24-hour after exercise
Primary	Concentration of CD4+		before exercise
Primary	Concentration of CD4+		immediately after exercise
Primary	Concentration of CD4+		2-hour after exercise
Primary	Concentration of CD4+		4-hour after exercise
Primary	Concentration of CD4+		8-hour after exercise
Primary	Concentration of CD4+		24-hour after exercise
Primary	Concentration of CD8+		before exercise
Primary	Concentration of CD8+		immediately after exercise
Primary	Concentration of CD8+		2-hour after exercise
Primary	Concentration of CD8+		4-hour after exercise
Primary	Concentration of CD8+		8-hour after exercise
Primary	Concentration of CD8+		24-hour after exercise
Primary	Concentration of CD19+		before exercise
Primary	Concentration of CD19+		immediately after exercise
Primary	Concentration of CD19+		2-hour after exercise
Primary	Concentration of CD19+		4-hour after exercise
Primary	Concentration of CD19+		8-hour after exercise
Primary	Concentration of CD19+		24-hour after exercise
Primary	Concentration of CD56+		before exercise
Primary	Concentration of CD56+		immediately after exercise
Primary	Concentration of CD56+		2-hour after exercise
Primary	Concentration of CD56+		4-hour after exercise
Primary	Concentration of CD56+		8-hour after exercise
Primary	Concentration of CD56+		24-hour after exercise
Primary	Concentration of IgA		before exercise
Primary	Concentration of IgA		immediately after exercise
Primary	Concentration of IgA		2-hour after exercise
Primary	Concentration of IgA		4-hour after exercise
Primary	Concentration of IgA		8-hour after exercise
Primary	Concentration of IgA		24-hour after exercise
Primary	Concentration of Cathelicidin		before exercise
Primary	Concentration of Cathelicidin		immediately after exercise
Primary	Concentration of Cathelicidin		2-hour after exercise
Primary	Concentration of Cathelicidin		4-hour after exercise
Primary	Concentration of Cathelicidin		8-hour after exercise
Primary	Concentration of Cathelicidin		24-hour after exercise
Primary	Concentration of TNF-a		before exercise
Primary	Concentration of TNF-a		immediately after exercise
Primary	Concentration of TNF-a		2-hour after exercise
Primary	Concentration of TNF-a		4-hour after exercise
Primary	Concentration of TNF-a		8-hour after exercise
Primary	Concentration of TNF-a		24-hour after exercise
Primary	Concentration of IL-1ß		before exercise
Primary	Concentration of IL-1ß		immediately after exercise
Primary	Concentration of IL-1ß		2-hour after exercise
Primary	Concentration of IL-1ß		4-hour after exercise
Primary	Concentration of IL-1ß		8-hour after exercise
Primary	Concentration of IL-1ß		24-hour after exercise
Primary	Concentration of IFN-?		before exercise
Primary	Concentration of IFN-?		immediately after exercise
Primary	Concentration of IFN-?		2-hour after exercise
Primary	Concentration of IFN-?		4-hour after exercise
Primary	Concentration of IFN-?		8-hour after exercise
Primary	Concentration of IFN-?		24-hour after exercise
Primary	Concentration of IL-2		before exercise
Primary	Concentration of IL-2		immediately after exercise
Primary	Concentration of IL-2		2-hour after exercise
Primary	Concentration of IL-2		4-hour after exercise
Primary	Concentration of IL-2		8-hour after exercise
Primary	Concentration of IL-2		24-hour after exercise
Primary	Concentration of IL-4		before exercise
Primary	Concentration of IL-4		immediately after exercise
Primary	Concentration of IL-4		2-hour after exercise
Primary	Concentration of IL-4		4-hour after exercise
Primary	Concentration of IL-4		8-hour after exercise
Primary	Concentration of IL-4		24-hour after exercise
Primary	Concentration of IL-8		before exercise
Primary	Concentration of IL-8		immediately after exercise
Primary	Concentration of IL-8		2-hour after exercise
Primary	Concentration of IL-8		4-hour after exercise
Primary	Concentration of IL-8		8-hour after exercise
Primary	Concentration of IL-8		24-hour after exercise
Primary	Concentration of IL-10		before exercise
Primary	Concentration of IL-10		immediately after exercise
Primary	Concentration of IL-10		2-hour after exercise
Primary	Concentration of IL-10		4-hour after exercise
Primary	Concentration of IL-10		8-hour after exercise
Primary	Concentration of IL-10		24-hour after exercise
Primary	Concentration of TBARS		before exercise
Primary	Concentration of TBARS		immediately after exercise
Primary	Concentration of TBARS		2-hour after exercise
Primary	Concentration of TBARS		4-hour after exercise
Primary	Concentration of TBARS		8-hour after exercise
Primary	Concentration of TBARS		24-hour after exercise
Primary	Concentration of PC		before exercise
Primary	Concentration of PC		immediately after exercise
Primary	Concentration of PC		2-hour after exercise
Primary	Concentration of PC		4-hour after exercise
Primary	Concentration of PC		8-hour after exercise
Primary	Concentration of PC		24-hour after exercise
Primary	Concentration of SOD		before exercise
Primary	Concentration of SOD		immediately after exercise
Primary	Concentration of SOD		2-hour after exercise
Primary	Concentration of SOD		4-hour after exercise
Primary	Concentration of SOD		8-hour after exercise
Primary	Concentration of SOD		24-hour after exercise
Primary	Concentration of catalase		before exercise
Primary	Concentration of catalase		immediately after exercise
Primary	Concentration of catalase		2-hour after exercise
Primary	Concentration of catalase		4-hour after exercise
Primary	Concentration of catalase		8-hour after exercise
Primary	Concentration of catalase		24-hour after exercise
Primary	Concentration of GPx		before exercise
Primary	Concentration of GPx		immediately after exercise
Primary	Concentration of GPx		2-hour after exercise
Primary	Concentration of GPx		4-hour after exercise
Primary	Concentration of GPx		8-hour after exercise
Primary	Concentration of GPx		24-hour after exercise
Primary	Concentration of CK		before exercise
Primary	Concentration of CK		immediately after exercise
Primary	Concentration of CK		2-hour after exercise
Primary	Concentration of CK		4-hour after exercise
Primary	Concentration of CK		8-hour after exercise
Primary	Concentration of CK		24-hour after exercise
Primary	Concentration of LDH		before exercise
Primary	Concentration of LDH		immediately after exercise
Primary	Concentration of LDH		2-hour after exercise
Primary	Concentration of LDH		4-hour after exercise
Primary	Concentration of LDH		8-hour after exercise
Primary	Concentration of LDH		24-hour after exercise
Primary	Concentration of IL-6		before exercise
Primary	Concentration of IL-6		immediately after exercise
Primary	Concentration of IL-6		2-hour after exercise
Primary	Concentration of IL-6		4-hour after exercise
Primary	Concentration of IL-6		8-hour after exercise
Primary	Concentration of IL-6		24-hour after exercise
Primary	Concentration of CRP		before exercise
Primary	Concentration of CRP		immediately after exercise
Primary	Concentration of CRP		2-hour after exercise
Primary	Concentration of CRP		4-hour after exercise
Primary	Concentration of CRP		8-hour after exercise
Primary	Concentration of CRP		24-hour after exercise