Biocomparison Study

Plain-language guide to NCT01638182: not phased randomized trial of Vitamin D, K2, Magnesium and Zinc, 81 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT01638182
Phase: not phased
Status: completed
Start: 2011-03
Completion (planned or actual): 2011-06
Participants: 81 (actual)
Design: randomized, double-blind, treatment
Conditions studied: Bone Health; Vascular Health
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.

27 participants received for 3 months 1 placebo capsule per day.

The registry classes the interventions as dietary supplement.

More on the Plan

Vitamin K is a group name for the naturally occurring phylloquinone (K1) and menaquinones (MK-n; K2).

The latter can be subdivided into the short-chain (e.g.

MK-4) and the long-chain (e.g.

MK-7, MK-8, and MK-9) menaquinones.

Who Took Part

Enrollment: 81 actual participants took part.

It was open to people of any sex aged from 20 years up to 80 years.

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

Examples of who could join: Healthy men and women, aged between 20-80 years. Normal body weight and height (18.5 kg/m2 \< BMI \< 30 kg/m2). Stable body weight (weight gain or loss \< 3 kg in past 3 mo). Written consent to take part in the study. Agreement to adhere to dietary restrictions required by the protocol.

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: abuse of drugs and/or alcohol; use of vitamin supplements containing vitamin k; (a history of) metabolic or gastrointestinal diseases, e.g. hepatic or renal disorders, osteoporosis.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Vitamin D, K2, Magnesium and Zinc group and the comparison group should start out alike.

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

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 2011-03 with completion listed for 2011-06.

It ran at 1 site in Netherlands.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: carboxylation of osteocalcin (time frame: 12 weeks).

It also tracked 1 secondary outcome, for example carboxylation of matrix-gla protein.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Vitamin D, K2, Magnesium and Zinc in 81 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.

Vitamin D, K2, Magnesium and Zinc in the library

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.