Vitamin C and Zinc in Patients With Enterocutaneous Fistulas.

Enterocutaneous Fistulas Clinical Trial

— VITAC  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06009744
• Other study ID #: HJM 005/32-I
• Status: Recruiting
• Phase: N/A
• Start date: August 2023
• Est. completion date: December 31, 2028

Study information

• Verified date: August 2023
• Source: Hospital Juarez de Mexico
• Contact: Elizabeth Pérez Cruz
• Phone: 525557477560
• Email: pece_liz[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Enterocutaneous Fistulas
• Fistula
• Intestinal Fistula

Intervention

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
• 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

Locations

Country	Name	City	State
Mexico	Hospital Juárez de México	Ciudad de México	Cdmx

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Juarez de Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fistula closure	Evaluate enterocutaneous fistula closure rate.	follow-up at 30 days
Primary	Recurrence of fistula	Evaluate the recurrence of enterocutaneous fistula	follow-up at 30 days
Secondary	Medical-nutritional status	Medical-nutritional status: subjective global assessment	24-72 hours after hospital admission
Secondary	Medical-nutritional status	Medical-nutritional status: nutritional risk index	24-72 hours after hospital admission
Secondary	biochemical markers	Changes in nutritional status biochemical markers: albumin in serum	every week until a maximum follow-up at 30 days
Secondary	biochemical markers	Changes in nutritional status biochemical markers: lymphocytes in serum.	every week until a maximum follow-up at 30 days
Secondary	biochemical markers	Changes in nutritional status biochemical markers: prealbumin in serum.	every week until a maximum follow-up at 30 days
Secondary	biochemical markers	Changes in nutritional status biochemical markers: transferrin in serum.	every week until a maximum follow-up at 30 days
Secondary	Metabolic profile	Changes in metabolic profile in serum glucose concentration	every week until a maximum follow-up at 30 days
Secondary	Metabolic profile	Changes in metabolic profile in serum tests liver	every 15 days up to a maximum follow-up at 30 days
Secondary	Length of hospital stay of patients	Determine the length of hospital stay of patients.	follow-up at 30 days