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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- Fistula closure
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Vit C y zinc bajo
Parenteral nutrition + Vitamin C 100-300 mg/d y zinc 3-5 mg/d
Intervention: Low-dose vitamin C and zinc (Drug)
Vit C and zinc alto
Parenteral nutrition + Vitamin C 1000-2000 mg/d y zinc 10-15 mg/d
Intervention: High-dose vitamin C and zinc (Drug)
Outcomes
Primary Outcomes
Fistula closure
Time Frame: follow-up at 30 days
Evaluate enterocutaneous fistula closure rate.
Recurrence of fistula
Time Frame: follow-up at 30 days
Evaluate the recurrence of enterocutaneous fistula
Secondary Outcomes
- Length of hospital stay of patients(follow-up at 30 days)
- biochemical markers(every week until a maximum follow-up at 30 days)
- Medical-nutritional status(24-72 hours after hospital admission)
- Metabolic profile(every 15 days up to a maximum follow-up at 30 days)
Investigators
ELIZABETH PEREZ CRUZ
MD, MSc, Prof.
Hospital Juarez de Mexico