VITAC: Vitamin C and Zinc in Patients With Enterocutaneous Fistulas.
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Sham Comparator: Vit C y zinc bajo Parenteral nutrition + Vitamin C 100-300 mg/d y zinc 3-5 mg/d |
Drug: Low-dose vitamin C and zinc
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
Other Names:
|
| Active Comparator: Vit C and zinc alto Parenteral nutrition + Vitamin C 1000-2000 mg/d y zinc 10-15 mg/d |
Drug: High-dose vitamin C and zinc
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
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Fistula closure [follow-up at 30 days]
Evaluate enterocutaneous fistula closure rate.
- Recurrence of fistula [follow-up at 30 days]
Evaluate the recurrence of enterocutaneous fistula
Secondary Outcome Measures
- Medical-nutritional status [24-72 hours after hospital admission]
Medical-nutritional status: subjective global assessment
- Medical-nutritional status [24-72 hours after hospital admission]
Medical-nutritional status: nutritional risk index
- biochemical markers [every week until a maximum follow-up at 30 days]
Changes in nutritional status biochemical markers: albumin in serum
- biochemical markers [every week until a maximum follow-up at 30 days]
Changes in nutritional status biochemical markers: lymphocytes in serum.
- biochemical markers [every week until a maximum follow-up at 30 days]
Changes in nutritional status biochemical markers: prealbumin in serum.
- biochemical markers [every week until a maximum follow-up at 30 days]
Changes in nutritional status biochemical markers: transferrin in serum.
- Metabolic profile [every week until a maximum follow-up at 30 days]
Changes in metabolic profile in serum glucose concentration
- Metabolic profile [every 15 days up to a maximum follow-up at 30 days]
Changes in metabolic profile in serum tests liver
- Length of hospital stay of patients [follow-up at 30 days]
Determine the length of hospital stay of patients.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Women and men
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18 years and <70 years old.
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Diagnosis of high-output enterocutaneous fistula for the first time
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Need for parenteral nutrition
Exclusion Criteria:
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Octreotide use
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Palliative care
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Steroid use
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Oxalate nephropathy
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G6PD deficiency
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Hemochromatosis
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Abdominal surgeries in the last 6 months
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Hospitalizations for more than 15 days in the last 6 months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Juárez de México | Ciudad de México | Cdmx | Mexico | 07760 |
Sponsors and Collaborators
- Hospital Juarez de Mexico
Investigators
- Principal Investigator: Elizabeth Pérez Cruz, Hospital Juarez de Mexico
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- HJM 005/32-I