Vitamin C and Zinc in Patients With Enterocutaneous Fistulas. (VITAC)

Hospital Juarez de Mexico

Status: Enrolling

Conditions: Enterocutaneous Fistulas

Treatments: Drug: High-dose vitamin C and zinc; Drug: Low-dose vitamin C and zinc

Study type: Interventional

Funder types: Other

Identifiers

NCT06009744

HJM 005/32-I

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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76 participants in 2 patient groups

Vit C y zinc bajo

Sham Comparator group

Description:

Parenteral nutrition + Vitamin C 100-300 mg/d y zinc 3-5 mg/d

Treatment:

Drug: Low-dose vitamin C and zinc

Vit C and zinc alto

Active Comparator group

Description:

Parenteral nutrition + Vitamin C 1000-2000 mg/d y zinc 10-15 mg/d

Treatment:

Drug: High-dose vitamin C and zinc