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Vitamin C and Zinc in Patients With Enterocutaneous Fistulas.

Vitamin C and Zinc in Patients With Enterocutaneous Fistulas.

Recruiting
18-70 years
All
Phase N/A

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Overview

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.

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

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

Study details
    Enterocutaneous Fistulas

NCT06009744

Hospital Juarez de Mexico

27 January 2024

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