Clinical trial

Efficacy of L-methylfolate and Methylcobalamine in Treating Hypertension and Its Impact on Serum Homocysteine in Hemodialysis Patients With Resistant Hypertension

Name

0107591

Description

The aim of the study is to evaluate the efficacy of L-methylfolate in combination with methylcobalamine in reducing homocysteine blood levels in hypertensive end-stage renal disease patients on regular hemodialysis and its association with blood pressure control in treatment of resistant hypertension

Trial arms

Trial start

2023-04-01

Estimated PCD

2024-05-01

Trial end

2024-05-01

Status

Active (not recruiting)

Phase

Early phase I

Treatment

L-Methyl Folate and methylcobalamine

Dietary supplement labeled to contain methylfolate 800 micrograms and methylcobalamine 1000 micrograms

Arms:

Experimental: Intervention group

Size

Primary endpoint

average pre-dialysis blood pressure target of ≤ 140/90 mm Hg or an average post-dialysis blood pressure target of ≤ 130/80 mm Hg

3 months

Eligibility criteria

Inclusion Criteria: * Adult end stage renal disease patients maintained on hemodialysis three times a week for at least 3 months with resistant hypertension as determined by pre-dialysis BP \> 140/90 mm Hg, post-dialysis BP \> 130/80 mm Hg despite the use of three or more drugs Exclusion Criteria: * Age \> 75 years * Excessive use of alcohol or smoking * Severe hepatic impairment * Acute kidney injury on top of chronic kidney disease * Pregnant females * Allergy or intolerance to any component of the formulation * Medication side effects (methotrexate, theophylline, phenytoin, and cyclosporine) or any drug proven to cause hyperhomocysteinemia

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'open-label, single-center, randomized controlled trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 51, 'type': 'ACTUAL'}}

Updated at

2024-01-30

1 organization

1 product

3 indications

Organization

Alexandria University

Product

L-Methyl Folate and Methylcobalamin

Indication

End-Stage Renal Disease

Indication

Hypertension

Indication

Renal