NCT05779410

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 22, 2023

Completed
Last Updated

March 22, 2023

Status Verified

February 1, 2023

Enrollment Period

11 months

First QC Date

February 20, 2023

Last Update Submit

March 9, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (162)

  • 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

    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

    4-hour after exercise

  • Concentration of basophil

    8-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

    4-hour after exercise

  • Concentration of monocyte

    8-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

    4-hour after exercise

  • Concentration of lymphocyte

    8-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+

    4-hour after exercise

  • Concentration of CD4+

    8-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+

    4-hour after exercise

  • Concentration of CD8+

    8-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+

    4-hour after exercise

  • Concentration of CD19+

    8-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+

    4-hour after exercise

  • Concentration of CD56+

    8-hour after exercise

  • Concentration of CD56+

    24-hour after exercise

  • Concentration of IgA

    before exercise

  • Concentration of IgA

    immediately after exercise

  • Concentration of IgA

    2-hour after exercise

  • Concentration of IgA

    4-hour after exercise

  • Concentration of IgA

    8-hour after exercise

  • Concentration of IgA

    24-hour after exercise

  • Concentration of Cathelicidin

    before exercise

  • Concentration of Cathelicidin

    immediately after exercise

  • Concentration of Cathelicidin

    2-hour after exercise

  • Concentration of Cathelicidin

    4-hour after exercise

  • Concentration of Cathelicidin

    8-hour after exercise

  • Concentration of Cathelicidin

    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

    4-hour after exercise

  • Concentration of TNF-α

    8-hour after exercise

  • Concentration of TNF-α

    24-hour after exercise

  • Concentration of IL-1β

    before exercise

  • Concentration of IL-1β

    immediately after exercise

  • Concentration of IL-1β

    2-hour after exercise

  • Concentration of IL-1β

    4-hour after exercise

  • Concentration of IL-1β

    8-hour after exercise

  • Concentration of IL-1β

    24-hour after exercise

  • Concentration of IFN-γ

    before exercise

  • Concentration of IFN-γ

    immediately after exercise

  • Concentration of IFN-γ

    2-hour after exercise

  • Concentration of IFN-γ

    4-hour after exercise

  • Concentration of IFN-γ

    8-hour after exercise

  • Concentration of IFN-γ

    24-hour after exercise

  • Concentration of IL-2

    before exercise

  • Concentration of IL-2

    immediately after exercise

  • Concentration of IL-2

    2-hour after exercise

  • Concentration of IL-2

    4-hour after exercise

  • Concentration of IL-2

    8-hour after exercise

  • Concentration of IL-2

    24-hour after exercise

  • Concentration of IL-4

    before exercise

  • Concentration of IL-4

    immediately after exercise

  • Concentration of IL-4

    2-hour after exercise

  • Concentration of IL-4

    4-hour after exercise

  • Concentration of IL-4

    8-hour after exercise

  • Concentration of IL-4

    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

    4-hour after exercise

  • Concentration of IL-8

    8-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

    4-hour after exercise

  • Concentration of IL-10

    8-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

    4-hour after exercise

  • Concentration of TBARS

    8-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

    4-hour after exercise

  • Concentration of PC

    8-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

    4-hour after exercise

  • Concentration of SOD

    8-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

    4-hour after exercise

  • Concentration of catalase

    8-hour after exercise

  • Concentration of catalase

    24-hour after exercise

  • Concentration of GPx

    before exercise

  • Concentration of GPx

    immediately after exercise

  • Concentration of GPx

    2-hour after exercise

  • Concentration of GPx

    4-hour after exercise

  • Concentration of GPx

    8-hour after exercise

  • Concentration of GPx

    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

    4-hour after exercise

  • Concentration of CK

    8-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

    4-hour after exercise

  • Concentration of LDH

    8-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

    4-hour after exercise

  • Concentration of IL-6

    8-hour after exercise

  • Concentration of IL-6

    24-hour after exercise

  • Concentration of CRP

    before exercise

  • Concentration of CRP

    immediately after exercise

  • Concentration of CRP

    2-hour after exercise

  • Concentration of CRP

    4-hour after exercise

  • Concentration of CRP

    8-hour after exercise

  • Concentration of CRP

    24-hour after exercise

Study Arms (2)

Vitamin D group

EXPERIMENTAL
Dietary Supplement: Vitamin D

Placebo group

PLACEBO COMPARATOR
Dietary Supplement: Medium-chain triglycerides

Interventions

Vitamin DDIETARY_SUPPLEMENT

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

Also known as: Liquid Shield Vitamin D3+E
Vitamin D group
Medium-chain triglyceridesDIETARY_SUPPLEMENT

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

Placebo group

Eligibility Criteria

Age20 Years - 40 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsThe 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.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The volunteers included have conditions as stated below :
  • no 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

You may not qualify if:

  • 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/min
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University

Taipei, 110, Taiwan

Location

MeSH Terms

Interventions

Vitamin D

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
A double-blind, matched-pair study design
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Healthy male participants were divided into vitamin D group and placebo group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2023

First Posted

March 22, 2023

Study Start

January 20, 2021

Primary Completion

December 8, 2021

Study Completion

December 8, 2021

Last Updated

March 22, 2023

Record last verified: 2023-02

Locations

TW(1)