Clinical trial NCT06009744: Vitamin C and Zinc in Patients With Enterocutaneous Fistulas.
Official title: Effectiveness of Doses of Vitamin c and Zinc in Patients With High Enterocutaneous Fistulas Receiving Nutrition Parenteral Therapy on Closure and Recurrence. Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Enterocutaneous Fistulas
Keywords: enterocutaneous fistulas
Vitamin C
Zinc
Parenteral nutrition
Lead sponsor: Hospital Juarez de Mexico
Sponsor class: OTHER_GOV
First posted: 2023-08-24
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* Women and men
* \>18 years and \<70 years old.
* Diagnosis of high-output enterocutaneous fistula for the first time
* Need for parenteral nutrition

Exclusion Criteria:

* Octreotide use
* Palliative care
* Steroid use
* Oxalate nephropathy
* G6PD deficiency
* Hemochromatosis
* Abdominal surgeries in the last 6 months
* Hospitalizations for more than 15 days in the last 6 months

Primary outcomes:
measure: Fistula closure
timeFrame: follow-up at 30 days
measure: Recurrence of fistula
timeFrame: follow-up at 30 days
Secondary outcomes:
measure: Medical-nutritional status
timeFrame: 24-72 hours after hospital admission
measure: Medical-nutritional status
timeFrame: 24-72 hours after hospital admission
measure: biochemical markers
timeFrame: every week until a maximum follow-up at 30 days
measure: biochemical markers
timeFrame: every week until a maximum follow-up at 30 days
measure: biochemical markers
timeFrame: every week until a maximum follow-up at 30 days
measure: biochemical markers
timeFrame: every week until a maximum follow-up at 30 days
measure: Metabolic profile
timeFrame: every week until a maximum follow-up at 30 days
measure: Metabolic profile
timeFrame: every 15 days up to a maximum follow-up at 30 days
measure: Length of hospital stay of patients
timeFrame: follow-up at 30 days
Other outcomes:
Locations:
city: Ciudad de México
country: Mexico
facility: Hospital Juárez de México
state: Cdmx
Study officials:
affiliation: Hospital Juarez de Mexico
name: Elizabeth Pérez Cruz
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.