A Randomized, Placebo-controlled, Double Blind Trial to Investigate Whether Vitamin K2 Can Influence Arterial Calcification in Patients With Type 2 Diabetes

What Was Tested

The trial (not phased) is built around Vitamin D, K2, Magnesium and Zinc.

It had two arms (groups): Vitamin K (experimental) and Placebo (placebo comparator).

One group receives placebo tablets daily.

The registry classes the interventions as dietary supplement.

Who Took Part

Enrollment: 68 actual participants took part.

It was open to people of any sex aged from 40 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Middle aged men and women, ≥ 40 years. Diagnosed with type 2 diabetes. Presence of arterial diseases, based on an Ankle Brachial Index (ABI) \<0.9 and/or diagnosed with arterial diseases by physician. Written informed consent.

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: subjects participate in another intervention research or study using imaging; contra-indication for undergoing18f-naf pet/ct scan (claustrophobia, pregnancy, breastfeeding); subject underwent amputation of the lower extremities (above the knee).

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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

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

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, care provider, investigator and outcomes assessor.

It started in 2016-06 with completion listed for 2018-09.

It ran at 1 site in Netherlands.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Absolute change in ongoing calcium deposition quantified as volumetric bone metabolic rate (CSUVMEAN x cm3) in the femoral artery between baseline and 6 months after baseline, as determined by 18F-NaF PET/CT imaging (time frame: 6 months).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Vitamin D, K2, Magnesium and Zinc in 68 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.