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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.
This is a randomized, control trial to investigate the effect and safety of doses of vitamin c and zinc in patients with high enterocutaneous fistulas receiving who need nutrition parenteral therapy on closure and recurrence.
Screening will be made to select eligible participants before intervention. Participants were randomly assigned to one of two groups: group a) 25-35 kcal/K/d, 1.3-1.5 g/K/d of amino acids and C 100-300 mg/d y zinc 3-5 mg/d; group b) 25-35 kcal/K/d, 1.3-1.5 g/K/d of amino acids and Vitamin C 1000-2000 mg/d y zinc 10-15 mg/d.
Demographic variables and subjective global assessment scale will be recorded and applied. Anthropometric measurements (weight and body mass index) will be evaluated upon admission and weekly until hospital discharge.
Biochemical markers (albumin, lymphocytes, prealbumin, transferrin, cholesterol, creatinine) and serum metabolic profile (glucose, liver function test) will be measured weekly. During hospitalization, patients will be evaluated daily until the closure of the fistula and/or follow-up at 30 days, monitoring capillary blood glucose, insulin expenditure, and fistula volume.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vit C y zinc bajo | Sham Comparator | Parenteral nutrition + Vitamin C 100-300 mg/d y zinc 3-5 mg/d |
|
| Vit C and zinc alto | Active Comparator | Parenteral nutrition + Vitamin C 1000-2000 mg/d y zinc 10-15 mg/d |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-dose vitamin C and zinc | Drug | This is a randomized, control trial to investigate the effect of Vitamin C and Zinc in patients with enterocutaneous fistulas receiving nutrition parenteral therapy and Vitamin C 100-300 mg/d and zinc 3-5 mg/d |
| Measure | Description | Time Frame |
|---|---|---|
| Fistula closure | Evaluate enterocutaneous fistula closure rate. | follow-up at 30 days |
| Recurrence of fistula | Evaluate the recurrence of enterocutaneous fistula | follow-up at 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Medical-nutritional status | Medical-nutritional status: subjective global assessment | 24-72 hours after hospital admission |
| Medical-nutritional status | Medical-nutritional status: nutritional risk index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Pérez Cruz | Contact | 525557477560 | 7497 | pece_liz@hotmail.com |
| Salvador Ortiz Gutiérrez | Contact | 525557477560 | 7497 | sortizgtz@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Pérez Cruz | Hospital Juarez de Mexico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Juárez de México | Recruiting | Mexico City | Mexico City | 07760 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19874952 | 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. | |
| 32404636 | 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. |
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| ID | Term |
|---|---|
| D007412 | Intestinal Fistula |
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| D015032 | Zinc |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Group a) 25-35 kcal/K/d, 1.3-1.5 g/K/d of amino acids and C 100-300 mg/d y zinc 3-5 mg/d Group b) 25-35 kcal/K/d, 1.3-1.5 g/K/d of amino acids and Vitamin C 1000-2000 mg/d y zinc 10-15 mg/d.
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|
| High-dose vitamin C and zinc | Drug | This is a randomized, control trial to investigate the effect of Vitamin C and Zinc in patients with enterocutaneous fistulas receiving nutrition parenteral therapy and Vitamin C 1000-2000 mg/d y zinc 10-15 mg/d |
|
|
| 24-72 hours after hospital admission |
| biochemical markers | Changes in nutritional status biochemical markers: albumin in serum | every week until a maximum follow-up at 30 days |
| biochemical markers | Changes in nutritional status biochemical markers: lymphocytes in serum. | every week until a maximum follow-up at 30 days |
| biochemical markers | Changes in nutritional status biochemical markers: prealbumin in serum. | every week until a maximum follow-up at 30 days |
| biochemical markers | Changes in nutritional status biochemical markers: transferrin in serum. | every week until a maximum follow-up at 30 days |
| Metabolic profile | Changes in metabolic profile in serum glucose concentration | every week until a maximum follow-up at 30 days |
| Metabolic profile | Changes in metabolic profile in serum tests liver | every 15 days up to a maximum follow-up at 30 days |
| Length of hospital stay of patients | Determine the length of hospital stay of patients. | follow-up at 30 days |
| 33368576 | 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. |
| 28385477 | 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. |
| 25455960 | 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. |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |