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Vitamin D Supplementation in Healthy Adults in Prolonged Endurance Exercise

NCT ID: NCT05781620

Last Updated: 2023-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-21

Study Completion Date

2024-02-29

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.

Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

An independent samples and dose titration design will be used to assign participants to the experimental group or placebo group.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
A double-blind, matched-pair study design

Study Groups

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Vitamin D group

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

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.

Placebo group

Group Type PLACEBO_COMPARATOR

Medium-chain triglycerides

Intervention Type DIETARY_SUPPLEMENT

Participants received the same amount of placebo matching vitamin D orally twice daily.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Medium-chain triglycerides

Participants received the same amount of placebo matching vitamin D orally twice daily.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Panion & BF Biotech Inc.

INDUSTRY

Sponsor Role collaborator

Taipei Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Taipei Medical University

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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NSTC111-2410-H-038 -015

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

N202205045

Identifier Type: -

Identifier Source: org_study_id