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Effects of Omega-3 Fatty Acids and Menaquinone-7 on Thrombotic Tendency

Plain-language guide to NCT00732576: not phased randomized trial of Vitamin D, K2, Magnesium and Zinc, 57 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT00732576
Phase
not phased
Status
completed
Start
2008-01
Completion (planned or actual)
2008-05
Participants
57 (actual)
Design
randomized, double-blind, prevention
Conditions studied
Atherosclerosis
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.

In this study the researchers investigate a potential synergy between the effects of either fish or krill oil and menaquinone-7, which is one of K2 vitamins.

It had eight arms (groups): 1 (active comparator), 2 (active comparator), 3 (active comparator), 4 (active comparator) and 5 (active comparator).

The registry classes the interventions as dietary supplement.

Who Took Part

57 actual participants took part.

It was open to people of any sex aged from 25 years up to 50 years.

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

Examples of who could join: Healthy subjects - BMI \< 30. Written informed consent.

The full record lists 2 inclusion and 5 exclusion criteria; among the exclusions: use of oral anticoagulants; coagulation disorders; use of multivitamin supplements.

How the Study Was Run

It was run as a randomized, parallel-group and double-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.

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

Neither the participants nor the staff measuring them knew who was on Vitamin D, K2, Magnesium and Zinc, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2008-01 with completion listed for 2008-05.

It ran at 1 site in Netherlands.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Endogenous Thrombin Potential (ETP) (time frame: 12 weeks).

It also tracked 2 secondary outcomes, for example Osteocalcin carboxylation and Matrix Gla-protein carboxylation.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Vitamin D, K2, Magnesium and Zinc in 57 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.