Vitamin D Supplementation in Healthy Adults in Prolonged Endurance Exercise

Healthy Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05781620
• Other study ID #: N202205045
• Secondary ID: NSTC111-2410-H-0
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 21, 2022
• Est. completion date: February 2024

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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.
• Medium-chain triglycerides
Participants received the same amount of placebo matching vitamin D orally twice daily.

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 NT-proBNP		before exercise
Primary	Concentration of NT-proBNP		immediately after exercise
Primary	Concentration of NT-proBNP		2-hour after exercise
Primary	Concentration of NT-proBNP		24-hour after exercise
Primary	Concentration of cTnI		before exercise
Primary	Concentration of cTnI		immediately after exercise
Primary	Concentration of cTnI		2-hour after exercise
Primary	Concentration of cTnI		24-hour after exercise
Primary	Concentration of CK-MB		before exercise
Primary	Concentration of CK-MB		immediately after exercise
Primary	Concentration of CK-MB		2-hour after exercise
Primary	Concentration of CK-MB		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		24-hour after exercise
Primary	Concentration of Testosterone		before exercise
Primary	Concentration of Testosterone		immediately after exercise
Primary	Concentration of Testosterone		2-hour after exercise
Primary	Concentration of Testosterone		24-hour after exercise
Primary	Concentration of Cortisol		before exercise
Primary	Concentration of Cortisol		immediately after exercise
Primary	Concentration of Cortisol		2-hour after exercise
Primary	Concentration of Cortisol		24-hour after exercise
Primary	Concentration of ß-endorphin		before exercise
Primary	Concentration of ß-endorphin		immediately after exercise
Primary	Concentration of ß-endorphin		2-hour after exercise
Primary	Concentration of ß-endorphin		24-hour after exercise
Primary	Concentration of Growth hormone		before exercise
Primary	Concentration of Growth hormone		immediately after exercise
Primary	Concentration of Growth hormone		2-hour after exercise
Primary	Concentration of Growth hormone		24-hour after exercise
Primary	Concentration of IGF-1		before exercise
Primary	Concentration of IGF-1		immediately after exercise
Primary	Concentration of IGF-1		2-hour after exercise
Primary	Concentration of IGF-1		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		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		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		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		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		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		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		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		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		24-hour after exercise
Primary	Concentration of IL-15		before exercise
Primary	Concentration of IL-15		immediately after exercise
Primary	Concentration of IL-15		2-hour after exercise
Primary	Concentration of IL-15		24-hour after exercise
Primary	Concentration of leukocyte		before exercise
Primary	Concentration of leukocyte		immediately after exercise
Primary	Concentration of leukocyte		2-hour after exercise
Primary	Concentration of leukocyte		24-hour after exercise
Primary	Concentration of neutrophil		before exercise
Primary	Concentration of neutrophil		immediately after exercise
Primary	Concentration of neutrophil		2-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		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		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		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		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+		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+		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+		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+		24-hour after exercise