What is the clinical evidence from this study?

Study design: RCT. Population: Type 2 diabetes mellitus with cardiovascular disease (n=68). Intervention: Vitamin K2 (menaquinone-7) vs. Placebo. Primary outcome: Total arterial calcification mass progression (β -0.02, 95% CI -0.10 to 0.06, p=0.64).

October 17, 2020European Journal of NutritionOpen Access

Six months vitamin K treatment does not affect systemic arterial calcification or bone mineral density in diabetes mellitus 2

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Key result

Vitamin K2 fails to slow arterial calcification progression or bone loss versus placebo.

β -0.02
95% CI -0.10 to 0.06
P=0.64
n=68

Why the study?

Vitamin K-dependent proteins are involved in vascular and bone calcification, and type 2 diabetes mellitus is associated with increased arterial calcification and fractures.

Does daily oral vitamin K2 supplementation reduce arterial calcification progression or slow bone mineral density decline in patients with type 2 diabetes mellitus and a history of cardiovascular disease?

Population

68 patients with DM2 and a history of CVD

Comparison

Daily oral 360 µg vitamin K2 vs placebo

Design

Pre-specified post hoc analysis of a double-blind randomized controlled trial

Follow-up

6 months

Authors

JBJonas W. BartstraUtrecht University FDFieke DraaismaRadboud University Nijmegen SZSabine R. ZwakenbergUtrecht University

Discussion

Member takes

Implication

Does not support vitamin K2 for arterial calcification or BMD in T2DM-CVD; confirms null effect in this RCT population.

Study Design

Type

RCT (n=68)

Blinding

Double-blind

Randomization

1:1 ratio, stratified by sex

Multicenter

Yes

Structured PICO

Population

68 adults over 40 years of age with type 2 diabetes and pre-existing cardiovascular disease, followed for 6 months.

Intervention

Vitamin K2 360 µg oral daily for 6 months

Comparator

Placebo for 6 months

Outcome

Systemic arterial calcification progression (total arterial calcification mass score) and bone mineral density (BMD) decline at 6 monthssurrogate

Main Result

Mean Difference: -0.02 (95% CI -0.1–0.06)

Absolute Event Rate: 84% vs 36%

p-value: p=0.64

Six months of vitamin K2 supplementation does not significantly affect systemic arterial calcification progression or bone mineral density in patients with type 2 diabetes and cardiovascular disease.

Limitations

Relatively high dropout rate, especially in the placebo arm
Study may have been underpowered to detect changes in BMD and CT-measured calcifications due to sample size calculation based on a different primary endpoint
Relatively short follow-up period of 6 months
Patients did not have very severe vitamin K deficiency at baseline
Significant baseline differences in arterial calcification mass scores between groups despite randomization
Study population was predominantly male (~75%), limiting generalizability
Coronary artery calcification mass scores might not be accurate due to the use of non-ECG-gated whole body CT scans
patients not pre-selected for very low vitamin K status
short follow-up time

Cite This Study

Bartstra et al. (2020) conducted an RCT in Type 2 diabetes mellitus with cardiovascular disease (n=68). Vitamin K2 (menaquinone-7) vs. Placebo was evaluated on Total arterial calcification mass progression (β -0.02, 95% CI -0.10 to 0.06, p=0.64). Six months of vitamin K2 supplementation did not significantly reduce systemic arterial calcification progression (β -0.02) or slow bone mineral density decline compared to placebo in patients with type 2 diabetes and cardiovascular disease.

synapsesocial.com/papers/6aa21c5d520b2d18c7efa00e https://doi.org/10.1007/s00394-020-02412-z

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Six months vitamin K treatment does not affect systemic arterial calcification or bone mineral density in diabetes mellitus 2

Discussion

Member takes

Implication

Study Design

Structured PICO

Main Result

Limitations

Cite This Study

Six months vitamin K treatment does not affect systemic arterial calcification or bone mineral density in diabetes mellitus 2

Discussion

Member takes

Implication

Study Design

Structured PICO

Main Result

Limitations

Cite This Study

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