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NCT Number: NCT06009744

Vitamin C and Zinc in Patients With Enterocutaneous Fistulas.

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.

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Juárez de México

Mexico City, 07760, Mexico

Location status: Recruiting

Location contact

Elizabeth PEREZ-CRUZ, MD

CONTACT

[email protected]

5557477560 ext. 7497

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Low Vit C y zinc

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

Other names: High Vit C y zinc

Primary outcomes

  1. Fistula closure

    Time frame: follow-up at 30 days

    Evaluate enterocutaneous fistula closure rate.

  2. Recurrence of fistula

    Time frame: follow-up at 30 days

    Evaluate the recurrence of enterocutaneous fistula

Secondary outcomes

  1. Medical-nutritional status

    Time frame: 24-72 hours after hospital admission

    Medical-nutritional status: subjective global assessment

  2. Medical-nutritional status

    Time frame: 24-72 hours after hospital admission

    Medical-nutritional status: nutritional risk index

  3. biochemical markers

    Time frame: every week until a maximum follow-up at 30 days

    Changes in nutritional status biochemical markers: albumin in serum

  4. biochemical markers

    Time frame: every week until a maximum follow-up at 30 days

    Changes in nutritional status biochemical markers: lymphocytes in serum.

  5. biochemical markers

    Time frame: every week until a maximum follow-up at 30 days

    Changes in nutritional status biochemical markers: prealbumin in serum.

  6. biochemical markers

    Time frame: every week until a maximum follow-up at 30 days

    Changes in nutritional status biochemical markers: transferrin in serum.

  7. Metabolic profile

    Time frame: every week until a maximum follow-up at 30 days

    Changes in metabolic profile in serum glucose concentration

  8. Metabolic profile

    Time frame: every 15 days up to a maximum follow-up at 30 days

    Changes in metabolic profile in serum tests liver

  9. Length of hospital stay of patients

    Time frame: follow-up at 30 days

    Determine the length of hospital stay of patients.

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Pérez Cruz

CONTACT

[email protected]

525557477560 ext. 7497

Salvador Ortiz Gutiérrez

CONTACT

[email protected]

525557477560 ext. 7497

Sponsors and collaborators

Lead sponsor

Hospital Juarez de Mexico

Other Gov

Registry information

Official study 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.

Acronym: VITAC

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Aug 24, 2023
Registry last updated
Aug 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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