drugset / Trial / NCT05807711
Efficacy of L-methylfolate and Methylcobalamine in Treating Resistant Hypertension Associated With Elevated Serum Homocysteine in Hemodialysis Patients.
RandomizedParallel-groupOpen-labelTreatment
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
Timeline
- Start
- 2023-04-01
- Primary completion
- 2024-05-01
- Completion
- 2024-05-01
Publications
- Background 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.
- Results 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 Nephrol. 2008;28(6):941-8. doi: 10.1159/000142363. Epub 2008 Jun 30.
- Results 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.
- Results 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.
- Salem MS, Hamdy NA, Elghoneimy HA, El Gowelli HM. Efficacy of L-methylfolate and methylcobalamin in treating resistant hypertension associated with elevated serum homocysteine in hemodialysis patients. BMC Nephrol. 2026 Jan 24;27(1):123. doi: 10.1186/s12882-025-04726-8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | L-methylfolate | Unknown | 800 ug | — |
| Comparator | methylcobalamine | Unknown | 1000 ug | — |