drugset / Trial / NCT06009744
Vitamin C and Zinc in Patients With Enterocutaneous Fistulas.
RandomizedParallel-groupTriple-blindTreatment
Summary
Various micronutrients play an important role in the process of closure and recurrence of enterocutaneous fistulas, such as Vitamin C and Zinc. However, there is no specific recommendation on the dose of these nutrients by parenteral route.
Timeline
- Start
- 2023-08
- Primary completion
- 2028-12-31
- Completion
- 2028-12-31
Publications
- Background Jeejeebhoy K. Zinc: an essential trace element for parenteral nutrition. Gastroenterology. 2009 Nov;137(5 Suppl):S7-12. doi: 10.1053/j.gastro.2009.08.014.
- Background Yanase F, Fujii T, Naorungroj T, Belletti A, Luethi N, Carr AC, Young PJ, Bellomo R. Harm of IV High-Dose Vitamin C Therapy in Adult Patients: A Scoping Review. Crit Care Med. 2020 Jul;48(7):e620-e628. doi: 10.1097/CCM.0000000000004396.
- Background Couper C, Doriot A, Siddiqui MTR, Steiger E. Nutrition Management of the High-Output Fistulae. Nutr Clin Pract. 2021 Apr;36(2):282-296. doi: 10.1002/ncp.10608. Epub 2020 Dec 24.
- Background Weimann A, Braga M, Carli F, Higashiguchi T, Hubner M, Klek S, Laviano A, Ljungqvist O, Lobo DN, Martindale R, Waitzberg DL, Bischoff SC, Singer P. ESPEN guideline: Clinical nutrition in surgery. Clin Nutr. 2017 Jun;36(3):623-650. doi: 10.1016/j.clnu.2017.02.013. Epub 2017 Mar 7.
- Background Girard E, Messager M, Sauvanet A, Benoist S, Piessen G, Mabrut JY, Mariette C. Anastomotic leakage after gastrointestinal surgery: diagnosis and management. J Visc Surg. 2014 Dec;151(6):441-50. doi: 10.1016/j.jviscsurg.2014.10.004. Epub 2014 Oct 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Vitamin C | Other / unclassified | 100 mg | Other |
| Comparator | Vitamin C | Other / unclassified | 300 mg | Other |
| Comparator | Vitamin C | Other / unclassified | 1000 mg | Other |
| Comparator | Vitamin C | Other / unclassified | 2000 mg | Other |
| Comparator | Zinc Sulfate | Unknown | 3 mg | Other |
| Comparator | Zinc Sulfate | Unknown | 5 mg | Other |
| Comparator | Zinc Sulfate | Unknown | 10 mg | Other |
| Comparator | Zinc Sulfate | Unknown | 15 mg | Other |