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Clinical Trial 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT06009744
Study type Interventional
Source Hospital Juarez de Mexico
Contact Elizabeth Pérez Cruz
Phone 525557477560
Email pece_liz@hotmail.com
Status Recruiting
Phase N/A
Start date August 2023
Completion date December 31, 2028

See also
  Status Clinical Trial Phase
Completed NCT01990833 - Molecular Characteristics of the Persistent Intestinal Fistulae After Glue Application N/A
Completed NCT01561066 - Autologous Fibrin Glues for Fistulas Closure Phase 1