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Comparison of Absorption of Vitamin K2

Plain-language guide to NCT00742768: not phased randomized trial of Vitamin D, K2, Magnesium and Zinc, 16 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT00742768
Phase
not phased
Status
completed
Start
2008-06
Completion (planned or actual)
2008-08
Participants
16 (actual)
Design
randomized, double-blind, treatment
Conditions studied
Healthy
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.

The Japanese soya product natto is one of the richest food sources of MK-7.

However, the taste of natto is not appreciated by the western society.

It had two arms (groups): 1 (active comparator) and 2 (active comparator).

Softgel capsules.

Gelpell capsules.

The registry classes the interventions as dietary supplement.

Who Took Part

16 actual participants took part.

It was open to people of any sex aged from 20 years up to 30 years.

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

Examples of who could join: Healthy men and women between 20 and 30 years old. Subjects of normal body weight and height according to BMI \< 30. Subjects of Caucasian race. Subject has given written consent to take part in the study.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: subjects with (a history of) metabolic or gastrointestinal disease; subjects presenting chronic degenerative and/or inflammatory disease; subjects receiving corticoϊd treatment.

How the Study Was Run

The set-up was randomized, crossover and double-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.

Each person switched between Vitamin D, K2, Magnesium and Zinc and the comparison at some point, usually with a gap in between.

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 and investigator.

It started in 2008-06 with completion listed for 2008-08.

It ran at 1 site in Netherlands.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The mean difference in plasma concentration of MK-4 and MK-7 between the two types of capsules (softgel or gelpell)concerns the primary outcome measure (time frame: 4 weeks).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Vitamin D, K2, Magnesium and Zinc in 16 people.

Its size is small, so on its own it can only give an early look.

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.