Comparative Study Evaluating the Effect of Vitamin K1 Versus Vitamin K2 on Vascular Calcification in Dialysis Patients

Ain Shams University

Status and phase: Completed; Phase 3; Phase 2

Conditions: End Stage Renal Disease on Dialysis

Treatments: Drug: Vitamin k2; Drug: Vitamin K1; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04477811

vitamin k in dialysis patients

Details and patient eligibility

About

To evaluate the effect of supplementation of vitamin K2 (menaquinone, MK-7)vs vitamin k1 on circulating levels of calcification regulators and to assess their safety in patients on regular dialysis patients.

Full description

Vascular calcification has emerged as an independent risk factor for cardiovascular morbidity and mortality, especially in chronic kidney disease .

It has a predictive value of poor prognoses and clinical outcomes in CKD patients such as overall mortality and even poor arteriovenous graft maturation .

Vitamin K is essential for the activation of matrix Gla protein (MGP), a powerful inhibitor of tissue calcification, functional vitamin K deficiency may contribute to high vascular calcification (VC) burden in haemodialysis patients; this is process in which mineral is pathologically deposited in blood vessels, mainly in large elastic and muscular arteries such as the aorta and the coronary, carotid, and peripheral arteries.

it is Prospective, Randomized,Placebo Controlled Study

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Both sexes aged between 18-75 years
2. Patients on HD greater than 3 months at least.
3. Stable clinical condition (no hospitalization in the previous 3 months)

Exclusion criteria

1. Hypersensitivity to vitamin k
2. Participant in an another clinical trial within the past 4 weeks.
3. Judged to be unsuitable as a subject by the attending physician.
4. Patients taking warfarin
5. Patients with known intestinal malabsorption
6. Patients with hypercoagulable state

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 3 patient groups, including a placebo group

vitamin k1

Active Comparator group

Description:

vitamin k1 will be given 10 mg thrice a week for 3 months

Treatment:

Drug: Vitamin K1

vitamin k2

Active Comparator group

Description:

vitamin k2 (menaquinone) will be given 90 ug per day orally

Treatment:

Drug: Vitamin k2

placebo

Placebo Comparator group

Description:

placebo will be given daily per oral for 3 months

Treatment:

Other: placebo