Vitamin D Supplementation in Healthy Adults in Prolonged Endurance Exercise

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Vitamin D
* Dietary Supplement: Medium-chain triglycerides


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: An independent samples and dose titration design will be used to assign participants to the experimental group or placebo group.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D group<br> | Dietary Supplement: Vitamin D<br>* 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.<br>|
| Placebo Comparator: Placebo group<br> | Dietary Supplement: Medium-chain triglycerides<br>* Participants received the same amount of placebo matching vitamin D orally twice daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of NT-proBNP |  | before exercise | 
| Concentration of NT-proBNP |  | immediately after exercise | 
| Concentration of NT-proBNP |  | 2-hour after exercise | 
| Concentration of NT-proBNP |  | 24-hour after exercise | 
| Concentration of cTnI |  | before exercise | 
| Concentration of cTnI |  | immediately after exercise | 
| Concentration of cTnI |  | 2-hour after exercise | 
| Concentration of cTnI |  | 24-hour after exercise | 
| Concentration of CK-MB |  | before exercise | 
| Concentration of CK-MB |  | immediately after exercise | 
| Concentration of CK-MB |  | 2-hour after exercise | 
| Concentration of CK-MB |  | 24-hour after exercise | 
| Concentration of CK |  | before exercise | 
| Concentration of CK |  | immediately after exercise | 
| Concentration of CK |  | 2-hour after exercise | 
| Concentration of CK |  | 24-hour after exercise | 
| Concentration of Testosterone |  | before exercise | 
| Concentration of Testosterone |  | immediately after exercise | 
| Concentration of Testosterone |  | 2-hour after exercise | 
| Concentration of Testosterone |  | 24-hour after exercise | 
| Concentration of Cortisol |  | before exercise | 
| Concentration of Cortisol |  | immediately after exercise | 
| Concentration of Cortisol |  | 2-hour after exercise | 
| Concentration of Cortisol |  | 24-hour after exercise | 
| Concentration of β-endorphin |  | before exercise | 
| Concentration of β-endorphin |  | immediately after exercise | 
| Concentration of β-endorphin |  | 2-hour after exercise | 
| Concentration of β-endorphin |  | 24-hour after exercise | 
| Concentration of Growth hormone |  | before exercise | 
| Concentration of Growth hormone |  | immediately after exercise | 
| Concentration of Growth hormone |  | 2-hour after exercise | 
| Concentration of Growth hormone |  | 24-hour after exercise | 
| Concentration of IGF-1 |  | before exercise | 
| Concentration of IGF-1 |  | immediately after exercise | 
| Concentration of IGF-1 |  | 2-hour after exercise | 
| Concentration of IGF-1 |  | 24-hour after exercise | 
| Concentration of TBARS |  | before exercise | 
| Concentration of TBARS |  | immediately after exercise | 
| Concentration of TBARS |  | 2-hour after exercise | 
| Concentration of TBARS |  | 24-hour after exercise | 
| Concentration of PC |  | before exercise | 
| Concentration of PC |  | immediately after exercise | 
| Concentration of PC |  | 2-hour after exercise | 
| Concentration of PC |  | 24-hour after exercise | 
| Concentration of SOD |  | before exercise | 
| Concentration of SOD |  | immediately after exercise | 
| Concentration of SOD |  | 2-hour after exercise | 
| Concentration of SOD |  | 24-hour after exercise | 
| Concentration of Catalase |  | before exercise | 
| Concentration of Catalase |  | immediately after exercise | 
| Concentration of Catalase |  | 2-hour after exercise | 
| Concentration of Catalase |  | 24-hour after exercise | 
| Concentration of TNF-α |  | before exercise | 
| Concentration of TNF-α |  | immediately after exercise | 
| Concentration of TNF-α |  | 2-hour after exercise | 
| Concentration of TNF-α |  | 24-hour after exercise | 
| Concentration of IL-8 |  | before exercise | 
| Concentration of IL-8 |  | immediately after exercise | 
| Concentration of IL-8 |  | 2-hour after exercise | 
| Concentration of IL-8 |  | 24-hour after exercise | 
| Concentration of IL-10 |  | before exercise | 
| Concentration of IL-10 |  | immediately after exercise | 
| Concentration of IL-10 |  | 2-hour after exercise | 
| Concentration of IL-10 |  | 24-hour after exercise | 
| Concentration of LDH |  | before exercise | 
| Concentration of LDH |  | immediately after exercise | 
| Concentration of LDH |  | 2-hour after exercise | 
| Concentration of LDH |  | 24-hour after exercise | 
| Concentration of IL-6 |  | before exercise | 
| Concentration of IL-6 |  | immediately after exercise | 
| Concentration of IL-6 |  | 2-hour after exercise | 
| Concentration of IL-6 |  | 24-hour after exercise | 
| Concentration of IL-15 |  | before exercise | 
| Concentration of IL-15 |  | immediately after exercise | 
| Concentration of IL-15 |  | 2-hour after exercise | 
| Concentration of IL-15 |  | 24-hour after exercise | 
| Concentration of leukocyte |  | before exercise | 
| Concentration of leukocyte |  | immediately after exercise | 
| Concentration of leukocyte |  | 2-hour after exercise | 
| Concentration of leukocyte |  | 24-hour after exercise | 
| Concentration of neutrophil |  | before exercise | 
| Concentration of neutrophil |  | immediately after exercise | 
| Concentration of neutrophil |  | 2-hour after exercise | 
| Concentration of neutrophil |  | 24-hour after exercise | 
| Concentration of eosinophil |  | before exercise | 
| Concentration of eosinophil |  | immediately after exercise | 
| Concentration of eosinophil |  | 2-hour after exercise | 
| Concentration of eosinophil |  | 24-hour after exercise | 
| Concentration of basophil |  | before exercise | 
| Concentration of basophil |  | immediately after exercise | 
| Concentration of basophil |  | 2-hour after exercise | 
| Concentration of basophil |  | 24-hour after exercise | 
| Concentration of monocyte |  | before exercise | 
| Concentration of monocyte |  | immediately after exercise | 
| Concentration of monocyte |  | 2-hour after exercise | 
| Concentration of monocyte |  | 24-hour after exercise | 
| Concentration of lymphocyte |  | before exercise | 
| Concentration of lymphocyte |  | immediately after exercise | 
| Concentration of lymphocyte |  | 2-hour after exercise | 
| Concentration of lymphocyte |  | 24-hour after exercise | 
| Concentration of CD4+ |  | before exercise | 
| Concentration of CD4+ |  | immediately after exercise | 
| Concentration of CD4+ |  | 2-hour after exercise | 
| Concentration of CD4+ |  | 24-hour after exercise | 
| Concentration of CD8+ |  | before exercise | 
| Concentration of CD8+ |  | immediately after exercise | 
| Concentration of CD8+ |  | 2-hour after exercise | 
| Concentration of CD8+ |  | 24-hour after exercise | 
| Concentration of CD19+ |  | before exercise | 
| Concentration of CD19+ |  | immediately after exercise | 
| Concentration of CD19+ |  | 2-hour after exercise | 
| Concentration of CD19+ |  | 24-hour after exercise | 
| Concentration of CD56+ |  | before exercise | 
| Concentration of CD56+ |  | immediately after exercise | 
| Concentration of CD56+ |  | 2-hour after exercise | 
| Concentration of CD56+ |  | 24-hour after exercise |