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viTAmin K2 and rEcOVery From ExeRcise

Plain-language guide to NCT04676958: not phased randomized trial of Vitamin D, K2, Magnesium and Zinc, 80 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT04676958
Phase
not phased
Status
completed
Start
2021-04-01
Completion (planned or actual)
2023-07-01
Participants
80 (actual)
Design
randomized, triple-blind, basic_science
Conditions studied
Inflammation; Oxidative Stress; Vitamin K; Exercise; Strength; Recovery
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Vitamin D, K2, Magnesium and Zinc.

The aim of the current study, therefore, is to investigate the effects of vitamin K2 supplementation on the physiological responses to an acute bout of resistance exercise.

It had two arms (groups): Placebo (placebo comparator) and Vitamin K2 (active comparator).

The registry classes the interventions as dietary supplement.

Who Took Part

80 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Participant is able and willing to sign the Informed Consent From. No plans to change lifestyle (activity and nutrition) during the study period. Older group (n=40): 65 years of age or older. Younger group (n=40): Aged 18-40 years.

The full record lists 4 inclusion and 15 exclusion criteria; among the exclusions: not currently, or in the last year, participating in more than 1h per week of vigorous aerobic physical activity or any resistance exercise; BMI \> 30 kg/m2; severe cardiovascular disease.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Because people in this Vitamin D, K2, Magnesium and Zinc study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Vitamin D, K2, Magnesium and Zinc group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Vitamin D, K2, Magnesium and Zinc.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2021-04-01 with completion listed for 2023-07-01.

It ran at 2 sites in United Kingdom (2).

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Change in post exercise recovery of muscle strength (time frame: Change from baseline to 12 weeks).

It also tracked 11 secondary outcomes, for example Change in pain free range of motion during knee extension exercise, Change in post exercise recovery of functional abilities, Change in post exercise recovery of sEMG activity, Change in post exercise interleukin-6, Change in post exercise peroxiredoxin 3 redox state and Change in vitamin K levels.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Vitamin D, K2, Magnesium and Zinc in 80 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Vitamin D, K2, Magnesium and Zinc compound page, all human trials.

Our Notes on the Compound

Vitamin D, K2, Magnesium and Zinc: Magnesium is described as required for AMPK to function.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.