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

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05807711
• Other study ID #: 0107591
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: April 1, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: March 2023
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

1. Ethical committee approval has been obtained from Ethics committee of Faculty of Medicine, Alexandria University

2. Agreement from all participants should be taken in this clinical study by assigning an informed consent

3. 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

4. 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.

5. A blood sample will be collected for homocysteine measurement at baseline

6. 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.

7. 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

8. As a measurement of the prognosis of elevated homocysteine, we should follow the development of myocardial infarction, stroke and cardiovascular events for 3 months

9. The appropriate statistical tests will be held according to the study design and parameters to evaluate the significance of the results

10. Results, conclusion, discussion and recommendations will be given

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 51
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Hypertension
• Hypertension, Renal
• Kidney Failure, Chronic

Intervention

Drug:
• L-Methyl Folate and methylcobalamine
Dietary supplement labeled to contain methylfolate 800 micrograms and methylcobalamine 1000 micrograms

Locations

Country	Name	City	State
Egypt	Faculty of Pharmacy, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Cianciolo G, La Manna G, Coli L, Donati G, D'Addio F, Persici E, Comai G, Wratten M, Dormi A, Mantovani V, Grossi G, Stefoni S. 5-methyltetrahydrofolate administration is associated with prolonged survival and reduced inflammation in ESRD patients. Am J N — View Citation

Friedman AN, Bostom AG, Selhub J, Levey AS, Rosenberg IH. The kidney and homocysteine metabolism. J Am Soc Nephrol. 2001 Oct;12(10):2181-2189. doi: 10.1681/ASN.V12102181. — View Citation

Go AS, Chertow GM, Fan D, McCulloch CE, Hsu CY. Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. N Engl J Med. 2004 Sep 23;351(13):1296-305. doi: 10.1056/NEJMoa041031. Erratum In: N Engl J Med. 2008;18(4):4. — View Citation

Li J, Jiang S, Zhang Y, Tang G, Wang Y, Mao G, Li Z, Xu X, Wang B, Huo Y. H-type hypertension and risk of stroke in chinese adults: A prospective, nested case-control study. J Transl Int Med. 2015 Oct-Dec;3(4):171-178. doi: 10.1515/jtim-2015-0027. Epub 2015 Dec 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	average pre-dialysis blood pressure target of = 140/90 mm Hg or an average post-dialysis blood pressure target of = 130/80 mm Hg	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	3 months
Secondary	myocardial infarction, stroke and cardiovascular events.	As a measurement of the prognosis patients will be followed up for the development of myocardial infarction, stroke and cardiovascular events for 3 months.	3 months