Vitamin C and Zinc in Patients With Enterocutaneous Fistulas.

Not Applicable

Recruiting

• Conditions: Enterocutaneous Fistulas
• Interventions: Drug: Low-dose vitamin C and zinc; Drug: High-dose vitamin C and zinc

• Registration Number: NCT06009744
• Lead Sponsor: Hospital Juarez de Mexico

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.

Study Timeline

• Study First Submitted: 2023-07-16
• Status Verified: 2023-08
• Study Start: 2023-08
• Study First Submitted QC: 2023-08-20
• Last Update Submitted: 2023-08-20
• Study First Posted: 2023-08-24
• Last Update Posted: 2023-08-24
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vit C y zinc bajo	Low-dose vitamin C and zinc	Parenteral nutrition + Vitamin C 100-300 mg/d y zinc 3-5 mg/d
Vit C and zinc alto	High-dose vitamin C and zinc	Parenteral nutrition + Vitamin C 1000-2000 mg/d y zinc 10-15 mg/d

Primary Outcome Measures

Name	Time	Method
Fistula closure	follow-up at 30 days	Evaluate enterocutaneous fistula closure rate.
Recurrence of fistula	follow-up at 30 days	Evaluate the recurrence of enterocutaneous fistula

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay of patients	follow-up at 30 days	Determine the length of hospital stay of patients.
biochemical markers	every week until a maximum follow-up at 30 days	Changes in nutritional status biochemical markers: transferrin in serum.
Medical-nutritional status	24-72 hours after hospital admission	Medical-nutritional status: nutritional risk index
Metabolic profile	every 15 days up to a maximum follow-up at 30 days	Changes in metabolic profile in serum tests liver

Trial Locations

Locations (1)

Hospital Juárez de México; 🇲🇽 Ciudad de México, Cdmx, Mexico