RecruitingNot ApplicableNCT06009744

Vitamin C and Zinc in Patients With Enterocutaneous Fistulas.

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.


Sponsor

Hospital Juarez de Mexico

Enrollment

76 participants

Start Date

Aug 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria4

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

Exclusion Criteria8

  • 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

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Interventions

DRUGLow-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

DRUGHigh-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


Locations(1)

Hospital Juárez de México

Mexico City, Mexico City, Mexico

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NCT06009744