Vitamin D Supplementation in Healthy Adults in Prolonged Endurance Exercise

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Vitamin D; Dietary supplement: Medium-chain triglycerides

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 110
    • Taipei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group	Dietary supplement: Medium-chain triglycerides; Participants received the same amount of placebo matching vitamin D orally twice daily.
Experimental: Vitamin D group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 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+	immediately after exercise
Concentration of CD56+	2-hour after exercise
Concentration of CD56+	24-hour after exercise
Concentration of CK-MB	before exercise
Concentration of CK-MB	2-hour after exercise
Concentration of CK-MB	24-hour after exercise
Concentration of CK-MB	immediately 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 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 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 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 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 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 CD56+	before exercise
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 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 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 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

Collaborators and Investigators

• Sponsor: Taipei Medical University
• Collaborators: Panion & BF Biotech Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2022
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: February 20, 2023
• First Submitted That Met QC Criteria: March 10, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: N202205045; NSTC111-2410-H-038 -015 (Other Grant/Funding Number: National Science and Technology Council)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No