Vitamin D in Healthy Adults After Strenuous Endurance Exe... | NCT05779410

Studies
Vitamin D in Healthy Adults After Strenuous Endurance Exercise

NCT05779410

Sponsor

Taipei Medical University

Status

Completed

Last Update Posted

Mar 22, 2023Actual

Enrollment

35Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Vitamin D
Medium-chain triglycerides

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
A-107-077	Other Grant/Funding Number	Panion & BF Biotech Inc.

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 20, 2021Actual

Primary Completion Date

Dec 8, 2021Actual

Completion Date

Dec 8, 2021Actual

First Submitted Date

Feb 20, 2023

First Submission Date that Met QC Criteria

Mar 9, 2023

First Posted Date

Mar 22, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2023

Last Update Posted Date

Mar 22, 2023Actual

Name	Class
Panion & BF Biotech Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vitamin D group	Experimental		Dietary Supplement: Vitamin D
Placebo group	Placebo Comparator		Dietary Supplement: Medium-chain triglycerides

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitamin D	Dietary Supplement	Participants received 5,000 IU of vitamin D orally twice daily for 4 weeks	Vitamin D group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Concentration of Neutrophil		before exercise
Concentration ofNeutrophil		immediately after exercise
Concentration of Neutrophil		2-hour after exercise
Concentration of Neutrophil		4-hour after exercise
Concentration of Neutrophil		8-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		4-hour after exercise
Concentration of eosinophil		8-hour after exercise
Concentration of eosinophil

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

The sample size is small due to the limited research funding. Additionally, considering the sports ability between men and women is significantly different, there would be a large standard deviation if we include both males and females. Thus our study includes male subjects only.

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D012632	Secosteroids
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds