NCT05781620

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

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

October 21, 2022

Completed
4 months 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 23, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

December 19, 2023

Status Verified

February 1, 2023

Enrollment Period

1.3 years

First QC Date

February 20, 2023

Last Update Submit

December 18, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (116)

  • 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 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 CK-MB

    before exercise

  • Concentration of CK-MB

    immediately after exercise

  • Concentration of CK-MB

    2-hour after exercise

  • Concentration of CK-MB

    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 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 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 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 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 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 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

  • 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 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 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+

    before exercise

  • Concentration of CD56+

    immediately after exercise

  • Concentration of CD56+

    2-hour after exercise

  • Concentration of CD56+

    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. 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.

Vitamin D group
Medium-chain triglyceridesDIETARY_SUPPLEMENT

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

Placebo group

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The volunteers included have conditions as stated below :
  • male adult between 20-40 years old without any 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/mint
  • 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: An independent samples and dose titration design will be used to assign participants to the experimental group or placebo group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2023

First Posted

March 23, 2023

Study Start

October 21, 2022

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

December 19, 2023

Record last verified: 2023-02

Locations

TW(1)