Vitamin D in Healthy Adults After Strenuous Endurance Exercise

NCT ID: NCT05779410

Last Updated: 2023-03-22

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

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-20

Study Completion Date

2021-12-08

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Healthy male participants were divided into vitamin D group and 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

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 for 4 weeks

Interventions

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Vitamin D

Participants received 5,000 IU of vitamin D orally twice daily for 4 weeks

Intervention Type DIETARY_SUPPLEMENT

Medium-chain triglycerides

Participants received the same amount of placebo matching vitamin D orally twice daily for 4 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Liquid Shield Vitamin D3+E

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

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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A-107-077

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

N202010026

Identifier Type: -

Identifier Source: org_study_id

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