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Antioxidant and Immune Effects of Vitamin K2
Plain-language guide to NCT05675163: 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
- NCT05675163
- Phase
- not phased
- Status
- completed
- Start
- 2022-11-15
- Completion (planned or actual)
- 2023-05-16
- Participants
- 60 (actual)
- Design
- randomized, triple-blind, basic_science
- Conditions studied
- Oxidative Stress; Inflammation
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this not phased trial, researchers set out to test Vitamin D, K2, Magnesium and Zinc.
It had three arms (groups): Placebo (placebo comparator), one (experimental) and one (experimental).
The registry classes the interventions as dietary supplement.
Who Took Part
The registry lists 60 actual participants took part.
It was open to people of any sex aged from 50 years up to 75 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Self-reported postmenopausal (at least one year after the final menstruation). BMI ≥25 and ≤32 kg/m2;. Non-smoking, defined as not smoking currently and not having smoked (at all) in the year before study start;. Healthy as assessed by the health questionnaire and according to the judgment of the study physician;. Having given written informed consent;.
The full record lists 8 inclusion and 17 exclusion criteria; among the exclusions: treatment with oral antibiotics within 2 months of the start of the study; any vaccination in the month before study start or any scheduled vaccination during the study period; use of antioxidant or vitamin k and d supplements;.
How the Study Was Run
It was run as a randomized, crossover and triple-blind study.
The participants were allocated by chance, so the Vitamin D, K2, Magnesium and Zinc group and the comparison group should start out alike.
Each person switched between Vitamin D, K2, Magnesium and Zinc and the comparison at some point, usually with a gap in between.
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 2022-11-15 with completion listed for 2023-05-16.
It ran at 1 site in Netherlands.
Its stated primary purpose is basic science.
What Was Measured
Researchers chose this as the main measure: plasma ox-LDL (time frame: 3 weeks).
It also tracked 5 secondary outcomes, for example plasma MDA, plasma CRP, IL-6, Phagocytosis capacity and PBMC gene expression.
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.
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.