The DANish COronary DEcalcification (DANCODE) Trial

NCT05500443 | Active Not Recruiting DMC

• 1 other identifier: DANCODE
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 3

Brief Summary

1\. Abstract Introduction Coronary artery calcification (CAC) and especially progression in CAC is a strong predictor of acute myocardial infarction and cardiovascular mortality. A substudy in the recent Danish study, AVADEC, suggested a protective role of supplementation with vitamin K2 and D in the development of CAC. This finding should be interpreted with caution, but the perspective is very interesting. In this study, we will examine the effect of the supplementation on progression of CAC in men and women with severe CAC. We hypothesize that the supplementation will slow down the calcification process. Method and analysis In this multicenter and double-blinded placebo-controlled study, 400 men and women with CAC score ≥ 400 are randomized (1:1) to treatment with vitamin K2 (720 µg/day) and vitamin D (25 µg/day) or placebo treatment (no active treatment) for two years. Exclusion criteria are treatment with vitamin K antagonist or coagulation disorders. To evaluate CAC score, a non-contrast CT-scan is performed at baseline and repeated after 12 and 24 months of follow-up. Primary outcome is difference in CAC score from baseline to follow-up at two years. Intention-to-treat principle is used for all analyses. Ethics and dissemination There are no reported adverse effects associated with the use of vitamin K2. Prior to inclusion, the protocol will be approved by the Regional Scientific Ethical Committee for Southern Denmark and the Data Protection Agency. It will be conducted in accordance with the Declaration of Helsinki. Positive as well as negative findings will be reported.

Conditions

Coronary Artery Disease

Keywords

Vitamin K2; Double-blinded, randomized, placebo-controlled study; Coronary artery calcification; Coronary artery plaque; Cardiac events

Outcome Measures

Primary Outcomes (1)

• Coronary artery calcium (CAC) score, all participants

  Change in CAC score

  From baseline to 24-months follow-up

Secondary Outcomes (7)

• CAC score, men only

  From baseline to 24-months follow-up

• CAC score, women only

  From baseline to 24-months follow-up

• CAC score below 1000 at baseline, all

  From baseline to 24-months follow-up

• CAC score above 1000 at baseline, all

  From baseline to 24-months follow-up

• Coronary plaque burden

  From baseline to 24-months follow-up

Study Arms (2)

Active treatment

EXPERIMENTAL

Tablets with vitamin k2 (Menaquinone-7 (MK-7)) 720 μg/day

Dietary Supplement: Vitamin K2 (Menaquinone-7)

Placebo

PLACEBO COMPARATOR

Tablets with placebo

Dietary Supplement: Vitamin K2 (Menaquinone-7)

Interventions

Vitamin K2 (Menaquinone-7) DIETARY_SUPPLEMENT

Oral supplementation with vitamin K2 (Menaquinone-7 (MK-7)) 720 µg/day and D 25 µg/day

Active treatment; Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Coronary artery calcium (CAC) score above 400

You may not qualify if:

• History of myocardial infarction or coronary revascularization
• History of venous thrombosis including pulmonary embolism
• Coagulation disorders
• Vitamin K antagonist use
• Disorders of calcium and phosphate metabolism (as primary hyperparathyroidism)
• Women of childbearing age (due to radiation issues)
• A life-expectancy \< 5 years

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (3)

Department of Cardiology, Odense University Hospital

Odense, Odense C, DK-5000, Denmark

Location

Department of Cardiology

Svendborg, Denmark

Location

Department of Cardiology

Vejle, Denmark

Location

Related Publications (1)

• Hasific S, Ovrehus KA, Hosbond S, Lambrechtsen J, Kumarathurai P, Mejldal A, Ravn EJ, Rasmussen LM, Gerke O, Mickley H, Diederichsen A. Effects of vitamins K2 and D3 supplementation in patients with severe coronary artery calcification: a study protocol for a randomised controlled trial. BMJ Open. 2023 Jul 14;13(7):e073233. doi: 10.1136/bmjopen-2023-073233.

  PMID: 37451735 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Cardiovascular Diseases

Interventions

Vitamin K 2; menaquinone 7

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Vitamin K; Naphthoquinones; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phytol; Diterpenes; Terpenes; Quinones; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The tablets have identical appearance, including taste, color, and size. The randomization-list is available to the data- and safety monitoring board, but patients, nurses, physicians and other data collectors are blinded to the allocation during the study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients are randomly assigned in a 1:1 ratio to either daily oral supplementation with vitamin K2 (Menaquinone-7 (MK-7)) (720 μg/day, K2VITAL®Delta) and D (25 μg/day) or placebo for 24 months. Treatment of both groups will last for at least 24 months. To evaluate progression in CAC score, a non-contrast CT-scan is performed at baseline and after 12 and 24 months of follow-up.

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 15, 2022
• Study Start: February 8, 2023
• Primary Completion: March 1, 2026
• Study Completion (Estimated): November 1, 2029
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After primary endpoint is published
• Access Criteria: Data are available on reasonable request

Locations

DK (3)