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Beneficial Effects of Long Term Menaquinone-7

Plain-language guide to NCT00642551: not phased randomized trial of Vitamin D, K2, Magnesium and Zinc, 240 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT00642551
Phase
not phased
Status
completed
Start
2008-03
Completion (planned or actual)
2011-09
Participants
240 (actual)
Design
randomized, double-blind, treatment
Conditions studied
Bone Loss; Arteriosclerosis
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.

It had two arms (groups): MK-7 (active comparator) and Placebo (placebo comparator).

1 placebo capsule per day for three years.

The registry classes the interventions as dietary supplement.

Who Took Part

240 actual participants took part.

It was open to women only aged from 55 years up to 65 years.

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

Examples of who could join: Healthy postmenopausal women between 55 and 65 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 12 exclusion criteria; among the exclusions: subjects with (a history of) metabolic or gastrointestinal disease; subjects presenting chronic degenerative and/or inflammatory disease; subjects receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters.

How the Study Was Run

It was run as a randomized, single-group and double-blind study.

Random assignment meant chance, not the researchers, decided who got Vitamin D, K2, Magnesium and Zinc and who got the comparison, which limits bias.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

Those kept unaware of assignments: participant and investigator.

It started in 2008-03 with completion listed for 2011-09.

It ran at 1 site in Netherlands.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Bone mineral density, bone mineral content and bone geometry measured by DEXA. Vascular elasticity, intima-media thickness and pulse wave velocity measured by ultrasound (time frame: three years).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Vitamin D, K2, Magnesium and Zinc in 240 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.