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NCT Number: NCT05807711

Efficacy of L-methylfolate and Methylcobalamine in Treating Resistant Hypertension Associated With Elevated Serum Homocysteine in Hemodialysis Patients.

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

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Key information

Conditions

End Stage Renal Disease Cardiovascular Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Hypertension, Renal Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Pharmacy, Alexandria University

Alexandria, Alexandria Governorate, 21521, Egypt

About this study

  • Ethical committee approval has been obtained from Ethics committee of Faculty of Medicine, Alexandria University
  • Agreement from all participants should be taken in this clinical study by assigning an informed consent
  • Adult end stage renal disease patients maintained on hemodialysis three times a week for at least 3 months with resistant hypertension will be recruited from hemodialysis unit in Alexandria University Hospitals
  • Patients will be screened for resistant hypertension as determined by the mean of mid-week pre-dialysis BP > 140/90 mm Hg, post-dialysis BP > 130/80 mm Hg over a period of one month.
  • A blood sample will be collected for homocysteine measurement at baseline
  • Patients will be randomized using simple randomization technique via computer based program to take one tablet daily containing L-methylfolate and methylcobalamine or no treatment.
  • Patients will be followed over a period of 3 months after which blood pressure measurement and blood sampling would be repeated and compared to baseline values
  • As a measurement of the prognosis of elevated homocysteine, we should follow the development of myocardial infarction, stroke and cardiovascular events for 3 months
  • The appropriate statistical tests will be held according to the study design and parameters to evaluate the significance of the results
  • Results, conclusion, discussion and recommendations will be given

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

L-Methyl Folate and methylcobalamine

Drug

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

Primary outcomes

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

    Time frame: 3 months

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

    This should be parallel to lowering of serum homocysteine compared to baseline values

Secondary outcomes

  1. myocardial infarction, stroke and cardiovascular events.

    Time frame: 3 months

    As a measurement of the prognosis patients will be followed up for the development of myocardial infarction, stroke and cardiovascular events for 3 months.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 11, 2023
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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