Vitamin C and Zinc in Patients With Enterocutaneous Fistulas.

Last updated: August 20, 2023
Sponsor: Hospital Juarez de Mexico
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ileus

Treatment

High-dose vitamin C and zinc

Low-dose vitamin C and zinc

Clinical Study ID

NCT06009744
HJM 005/32-I
  • Ages 18-70
  • All Genders

Study 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 Criteria

Inclusion

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

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 Design

Total Participants: 76
Treatment Group(s): 2
Primary Treatment: High-dose vitamin C and zinc
Phase:
Study Start date:
August 01, 2023
Estimated Completion Date:
December 31, 2028

Study 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.

Connect with a study center

  • Hospital Juárez de México

    Ciudad de México, Cdmx 07760
    Mexico

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.