Vitamin C and Zinc in Patients With Enterocutaneous Fistulas.

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Enterocutaneous Fistulas

Intervention / Treatment
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* Drug: Low-dose vitamin C and zinc
* Drug: High-dose vitamin C and zinc


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Vit C y zinc bajo<br>Parenteral nutrition + Vitamin C 100-300 mg/d y zinc 3-5 mg/d | Drug: Low-dose vitamin C and zinc<br>* 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<br>* Other names: Low Vit C y zinc;|
| Active Comparator: Vit C and zinc alto<br>Parenteral nutrition + Vitamin C 1000-2000 mg/d y zinc 10-15 mg/d | Drug: High-dose vitamin C and zinc<br>* 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<br>* Other names: High Vit C y zinc;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fistula closure | Evaluate enterocutaneous fistula closure rate. | follow-up at 30 days | 
| Recurrence of fistula | Evaluate the recurrence of enterocutaneous fistula | follow-up at 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical-nutritional status | Medical-nutritional status: subjective global assessment | 24-72 hours after hospital admission | 
| Medical-nutritional status | Medical-nutritional status: nutritional risk index | 24-72 hours after hospital admission | 
| biochemical markers | Changes in nutritional status biochemical markers: albumin in serum | every week until a maximum follow-up at 30 days | 
| biochemical markers | Changes in nutritional status biochemical markers: lymphocytes in serum. | every week until a maximum follow-up at 30 days | 
| biochemical markers | Changes in nutritional status biochemical markers: prealbumin in serum. | every week until a maximum follow-up at 30 days | 
| biochemical markers | Changes in nutritional status biochemical markers: transferrin in serum. | every week until a maximum follow-up at 30 days | 
| Metabolic profile | Changes in metabolic profile in serum glucose concentration | every week until a maximum follow-up at 30 days | 
| Metabolic profile | Changes in metabolic profile in serum tests liver | 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. | follow-up at 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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enterocutaneous fistulas, Vitamin C, Zinc, Parenteral nutrition