← Human Trials & Peer-Reviewed Studies

Vitamin K2 Supplements for Muscle Recovery

Plain-language guide to NCT05161975: not phased randomized trial of Vitamin D, K2, Magnesium and Zinc, 60 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05161975
Phase
not phased
Status
status unknown
Start
2021-12-15
Completion (planned or actual)
2023-10-31
Participants
60 (estimated)
Design
randomized, quadruple-blind, prevention
Conditions studied
Muscle Atrophy; Cachexia
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around Vitamin D, K2, Magnesium and Zinc.

Ankle injury is one of the most common injuries which can have long term consequences.

Ankle immobilization is often applied for up to six weeks to ensure healing of the soft tissue and fractured bones after such an injury.

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

Food supplement tablets do not contain vitamin K2.

Food supplement tablets contain vitamin K2.

The registry classes the interventions as dietary supplement.

More on the Plan

One such period of very low activity can occur following illness or injury.

Strategies to retard loss of muscle mass and function during inactivity are, thus, of critical importance in understanding of the mechanisms underlying such effects.

Vitamin K includes a group of structurally related compounds named phylloquinone (vitamin K1) and menaquinones (vitamin K2s) of which MK-4 and MK-7 are the most important.

There are 20 described vitamin K dependent proteins (VKDPs).

Who Took Part

60 planned participants were the target.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: 18-60 years of age;. Lives in Lithuania;. Able and willing to give informed written consent to participate in the study;. Recent (24 h before volunteering for the study) ankle injury requiring 6-week ankle immobilization;. Exercise training program during 6-week recovery is recommended.

The full record lists 5 inclusion and 12 exclusion criteria; among the exclusions: body mass index (bmi) is greater than 30 kg / m2;; diabetes complicates cardiovascular diseases,; liver disease;.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Vitamin D, K2, Magnesium and Zinc study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2021-12-15 with completion listed for 2023-10-31.

It ran at 2 sites in Lithuania (2).

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Muscle thickness (time frame: 12 weeks). Muscle strength (time frame: 12 weeks). Vitamin K2 status (time frame: 12 weeks).

It also tracked 4 secondary outcomes, for example Cytokine profile, Gene expression profile, Protein expression profile and Metabolic enzyme activity.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Vitamin D, K2, Magnesium and Zinc in 60 people.

Its status is unknown; 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.