Effect of MK-7 supplementation to dp-ucMGP levels in chronic hemodialysis patients receiving phosphate binders

Phase 4

• Conditions: Hemodialysis patients; hemodialysis, phosphate binders, MK7, menaquinone, vitaminK, dpucMGP

• Registration Number: TCTR20210525007
• Lead Sponsor: The College of Pharmacotherapy of Thailand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-25
• Study Completion: 2021-08-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.Thai adults chronic hemodialysis patients
2.Receiving monotherapy of phosphate binder

Exclusion Criteria

1.History of cardiovascular diseases
2.History of coagulation defects
3.History of malignancy
4.Presence of lipid absorption disorders
5.Elevated liver enzymes, above 3 times the upper limit of normal
6.Serum albumin less than 2.5 g/dL
7.Body mass index less than 18 kg/m2
8.VitaminK antagonists treatment within 90 days prior to recruitment
9.Concomitant drugs affect vitaminK levels e.g. carbamazepine, cholestyraine, lamotrigine, menadione, menaquinone, orlistat, oxcarbamazepine, phenobarbital, phenytoin, phytomenadione
10.Receiving antibiotics at least 10 days during recruitment
11.Phosphate binders dose adjustment within 30 days prior to recruitment
12.Hypersensitivity to menaquinone or any component of the formulation
13.Medication adherence less than 80%
14.Refuse to participate

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
dp-ucMGP per-post intervantion baseline and 8 weeks after the intervention dp-ucMGP

Secondary Outcome Measures

Name	Time	Method
dp-ucMGP between groups 8 weeks after the intervention dp-ucMGP