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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06009744
Recruitment Status : Recruiting
First Posted : August 24, 2023
Last Update Posted : August 24, 2023
Sponsor:
Information provided by (Responsible Party):
ELIZABETH PEREZ CRUZ, Hospital Juarez de Mexico

Study Description
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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.

Condition or disease Intervention/treatment Phase
Enterocutaneous Fistulas Drug: Low-dose vitamin C and zinc Drug: High-dose vitamin C and zinc Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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.
Estimated Study Start Date : August 2023
Estimated Primary Completion Date : December 31, 2028
Estimated Study Completion Date : December 31, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas Vitamin C

Arms and Interventions
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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 Name: 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 Name: High Vit C y zinc


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06009744


Contacts
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Contact: Elizabeth Pérez Cruz 525557477560 ext 7497 pece_liz@hotmail.com
Contact: Salvador Ortiz Gutiérrez 525557477560 ext 7497 sortizgtz@gmail.com

Locations
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Mexico
Hospital Juárez de México Recruiting
Ciudad de México, Cdmx, Mexico, 07760
Contact: Elizabeth PEREZ-CRUZ, MD    5557477560 ext 7497    pece_liz@yahoo.com.mx   
Sponsors and Collaborators
Hospital Juarez de Mexico
Investigators
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Principal Investigator: Elizabeth Pérez Cruz Hospital Juarez de Mexico
More Information
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Publications:

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Responsible Party: ELIZABETH PEREZ CRUZ, MD, MSc, Prof., Hospital Juarez de Mexico
ClinicalTrials.gov Identifier: NCT06009744    
Other Study ID Numbers: HJM 005/32-I
First Posted: August 24, 2023    Key Record Dates
Last Update Posted: August 24, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by ELIZABETH PEREZ CRUZ, Hospital Juarez de Mexico:
enterocutaneous fistulas
Vitamin C
Zinc
Parenteral nutrition
Additional relevant MeSH terms:
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Intestinal Fistula
Fistula
Pathological Conditions, Anatomical
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Vitamins
 Ascorbic Acid
Zinc
Micronutrients
Physiological Effects of Drugs
Trace Elements
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents