Vitamin C and Zinc in Patients With Enterocutaneous Fistulas.

NCT06009744 | Recruiting DMC

• 1 other identifier: HJM 005/32-I
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Enterocutaneous Fistulas

Keywords

enterocutaneous fistulas; Vitamin C; Zinc; Parenteral nutrition

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Medical-nutritional status

  24-72 hours after hospital admission

• Medical-nutritional status

  24-72 hours after hospital admission

• biochemical markers

  every week until a maximum follow-up at 30 days

• biochemical markers

  every week until a maximum follow-up at 30 days

• biochemical markers

  every week until a maximum follow-up at 30 days

Study Arms (2)

Vit C y zinc bajo

SHAM COMPARATOR

Parenteral nutrition + Vitamin C 100-300 mg/d y zinc 3-5 mg/d

Drug: Low-dose vitamin C and zinc

Vit C and zinc alto

ACTIVE COMPARATOR

Parenteral nutrition + Vitamin C 1000-2000 mg/d y zinc 10-15 mg/d

Drug: High-dose vitamin C and zinc

Interventions

Low-dose vitamin C and zinc DRUG

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

Also known as: Low Vit C y zinc

Vit C y zinc bajo

High-dose vitamin C and zinc DRUG

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

Also known as: High Vit C y zinc

Vit C and zinc alto

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women and men
• \>18 years and \<70 years old.
• Diagnosis of high-output enterocutaneous fistula for the first time
• Need for parenteral nutrition

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Juarez de Mexico: lead

Study Sites (1)

Hospital Juárez de México

Mexico City, Mexico City, 07760, Mexico

RECRUITING

Related Publications (5)

• 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.

  PMID: 19874952 BACKGROUND

• 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.

  PMID: 32404636 BACKGROUND

• 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.

  PMID: 33368576 BACKGROUND

• 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.

  PMID: 28385477 BACKGROUND

• 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.

  PMID: 25455960 BACKGROUND

MeSH Terms

Conditions

Intestinal Fistula; Hyperphagia

Interventions

Ascorbic Acid; Zinc

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Elizabeth Pérez Cruz

  Hospital Juarez de Mexico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Pérez Cruz

CONTACT

525557477560; pece_liz@hotmail.com

Salvador Ortiz Gutiérrez

CONTACT

525557477560; sortizgtz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc, Prof.

Model Details: 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.

Study Record Dates

• First Submitted: July 16, 2023
• First Posted: August 24, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)