Vitamin k1 and Its Relation to Vascular Calcification in Hemodialysis Patients

NCT05060809 | Completed Phase 4

• 1 other identifier: vit k in hemodialysis patient
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Vascular calcification (VC) represents one of the major complications associated with progressive renal impairment. Matrix Gla-protein (MGP) is a vitamin K-dependent protein that acts as a powerful inhibitor of vascular calcification. Despite this fact, it remains unknown whether supplementation with vitamin K can lead to reduction or reversal of vascular and heart valve calcification. Our study aims primarily to investigate the effect of intravenous vitamin K1 three times weekly for a total duration of 6 months on the serum levels of dephosphorylated-uncarboxylated MGP (dp-ucMGP) as well as aortic calcification score and severity of aortic and mitral valve lesions.

Conditions

Vascular Calcification

Keywords

hemodialysis; Vitamin k1

Outcome Measures

Primary Outcomes (1)

• Effect of vitamin k1 supplementation on vascular calcification

  Our study aims primarily to investigate the effect of oral vitamin K1 three times weekly for a total duration of 6 months on the serum levels of dephosphorylated-uncarboxylated MGP (dp-ucMGP) as well as aortic calcification score and severity of aortic and mitral valve lesions.

  6 months

Study Arms (1)

Hemodialysis patient with high level of dp uc-MGP

EXPERIMENTAL

one hundred and twenty hemodialysis patients with high level of dephosphorylated uc-MGP received 5 mg of oral vitamin K1 (phylloquinone) three times /week for 6 months at the end of HD session. We measured the serum dephosphorylated- uncarboxylated matrix Gla protein (dp-ucMGP) 6 months after vitamin K1 supplementation. In addition, plain lateral abdominal x-ray was conducted prior to and after 6 months of vitamin K supplementation to assess lumbar aorta calcification. The extent of aortic calcification score (AAC) was assessed by Kauppila score.In addition, study patients were subjected to an echocardiography at baseline as well as 6 months post vitamin K1 supplementation. Echocardiography was performed by the same operator.

Drug: oral vitamin k1 (phylloquinone)

Interventions

oral vitamin k1 (phylloquinone) DRUG

The enrolled patients received 5 mg of oral vitamin K1 (phylloquinone) three times /week for 6 months at the end of HD session to ensure compliance. We measured the serum dephosphorylated- uncarboxylated matrix Gla protein (dp-ucMGP) before and 6 months after vitamin K1 supplementation. In addition, plain lateral abdominal x-ray was conducted prior to and after 6 months of vitamin K supplementation to assess lumbar aorta calcification. The extent of aortic calcification score (AAC) was assessed by a semi-quantitative grading system developed by Kauppila.

Hemodialysis patient with high level of dp uc-MGP

Eligibility Criteria

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

You may qualify if:

• Males or females ≥18 years of age,
• Not less than 6 months on HD,
• High level of serum dephosphorylated uc-MGP
• Signed informed consent,

You may not qualify if:

• Patients with normal level of dp-ucMGP
• History of thrombosis,
• Intake of vitamin K antagonists (warfarin) at baseline or in the 3 months prior to baseline,
• Inflammatory bowel disease,
• Liver dysfunction,

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, 71515, Egypt

Location

Related Publications (2)

• Aoun M, Makki M, Azar H, Matta H, Chelala DN. High Dephosphorylated-Uncarboxylated MGP in Hemodialysis patients: risk factors and response to vitamin K2, A pre-post intervention clinical trial. BMC Nephrol. 2017 Jun 7;18(1):191. doi: 10.1186/s12882-017-0609-3.

  PMID: 28592319 BACKGROUND

• Krueger T, Schlieper G, Schurgers L, Cornelis T, Cozzolino M, Jacobi J, Jadoul M, Ketteler M, Rump LC, Stenvinkel P, Westenfeld R, Wiecek A, Reinartz S, Hilgers RD, Floege J. Vitamin K1 to slow vascular calcification in haemodialysis patients (VitaVasK trial): a rationale and study protocol. Nephrol Dial Transplant. 2014 Sep;29(9):1633-8. doi: 10.1093/ndt/gft459. Epub 2013 Nov 26.

  PMID: 24285427 BACKGROUND

MeSH Terms

Conditions

Vascular Calcification

Interventions

Vitamin K 1

Condition Hierarchy (Ancestors)

Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic 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: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 19, 2021
• First Posted: September 29, 2021
• Study Start: January 1, 2018
• Primary Completion: July 30, 2019
• Study Completion: January 1, 2020
• Last Updated: October 5, 2021

Record last verified: 2021-09

Locations

EG (1)