Vitamin C and Zinc in Patients With Enterocutaneous Fistulas. (VITAC)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Enterocutaneous Fistulas
• Intervention / Treatment: Drug: Low-dose vitamin C and zinc; Drug: High-dose vitamin C and zinc

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 Type: Interventional
• Enrollment (Estimated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elizabeth Pérez Cruz; Phone Number: 7497 525557477560; Email: pece_liz@hotmail.com
• Study Contact Backup: Name: Salvador Ortiz Gutiérrez; Phone Number: 7497 525557477560; Email: sortizgtz@gmail.com

Study Locations

• Mexico
  • Cdmx
    • Ciudad de México, Cdmx, Mexico, 07760
      • Recruiting
      • Hospital Juarez de Mexico
      • Contact: Elizabeth PEREZ-CRUZ, MD; Phone Number: 7497 5557477560; Email: pece_liz@yahoo.com.mx

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Juarez de Mexico
• Investigators: Principal Investigator: Elizabeth Pérez Cruz, Hospital Juarez de Mexico

Publications and helpful links

General Publications

• Weimann A, Braga M, Carli F, Higashiguchi T, Hubner M, Klek S, Laviano A, Ljungqvist O, Lobo DN, Martindale R, Waitzberg DL, Bischoff SC, Singer P. ESPEN guideline: Clinical nutrition in surgery. Clin Nutr. 2017 Jun;36(3):623-650. doi: 10.1016/j.clnu.2017.02.013. Epub 2017 Mar 7.
• Jeejeebhoy K. Zinc: an essential trace element for parenteral nutrition. Gastroenterology. 2009 Nov;137(5 Suppl):S7-12. doi: 10.1053/j.gastro.2009.08.014.
• Yanase F, Fujii T, Naorungroj T, Belletti A, Luethi N, Carr AC, Young PJ, Bellomo R. Harm of IV High-Dose Vitamin C Therapy in Adult Patients: A Scoping Review. Crit Care Med. 2020 Jul;48(7):e620-e628. doi: 10.1097/CCM.0000000000004396.
• Couper C, Doriot A, Siddiqui MTR, Steiger E. Nutrition Management of the High-Output Fistulae. Nutr Clin Pract. 2021 Apr;36(2):282-296. doi: 10.1002/ncp.10608. Epub 2020 Dec 24.
• Girard E, Messager M, Sauvanet A, Benoist S, Piessen G, Mabrut JY, Mariette C. Anastomotic leakage after gastrointestinal surgery: diagnosis and management. J Visc Surg. 2014 Dec;151(6):441-50. doi: 10.1016/j.jviscsurg.2014.10.004. Epub 2014 Oct 22.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: July 16, 2023
• First Submitted That Met QC Criteria: August 20, 2023
• First Posted (Actual): August 24, 2023

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 20, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Vitamin C; Zinc; Parenteral nutrition; enterocutaneous fistulas
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Digestive System Fistula; Fistula; Intestinal Fistula; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Trace Elements; Micronutrients; Antioxidants; Vitamins; Ascorbic Acid; Zinc
• Other Study ID Numbers: HJM 005/32-I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No