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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
76
This is a randomized, control trial to investigate the effect of Vitamin C and Zinc in patients with enterocutaneous fistulas receiving nutrition parenteral therapy and Vitamin C 100-300 mg/d and zinc 3-5 mg/d
This is a randomized, control trial to investigate the effect of Vitamin C and Zinc in patients with enterocutaneous fistulas receiving nutrition parenteral therapy and Vitamin C 1000-2000 mg/d y zinc 10-15 mg/d
Hospital Juárez de México
Mexico City, Mexico City, Mexico
RECRUITINGFistula closure
Evaluate enterocutaneous fistula closure rate.
Time frame: follow-up at 30 days
Recurrence of fistula
Evaluate the recurrence of enterocutaneous fistula
Time frame: follow-up at 30 days
Medical-nutritional status
Medical-nutritional status: subjective global assessment
Time frame: 24-72 hours after hospital admission
Medical-nutritional status
Medical-nutritional status: nutritional risk index
Time frame: 24-72 hours after hospital admission
biochemical markers
Changes in nutritional status biochemical markers: albumin in serum
Time frame: every week until a maximum follow-up at 30 days
biochemical markers
Changes in nutritional status biochemical markers: lymphocytes in serum.
Time frame: every week until a maximum follow-up at 30 days
biochemical markers
Changes in nutritional status biochemical markers: prealbumin in serum.
Time frame: every week until a maximum follow-up at 30 days
biochemical markers
Changes in nutritional status biochemical markers: transferrin in serum.
Time frame: every week until a maximum follow-up at 30 days
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Metabolic profile
Changes in metabolic profile in serum glucose concentration
Time frame: every week until a maximum follow-up at 30 days
Metabolic profile
Changes in metabolic profile in serum tests liver
Time frame: every 15 days up to a maximum follow-up at 30 days
Length of hospital stay of patients
Determine the length of hospital stay of patients.
Time frame: follow-up at 30 days