Using Vitamin C and Zinc to Treat Enterocutaneous Fistulas
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.
This study is testing whether different doses of vitamin C and zinc can help close and prevent the return of enterocutaneous fistulas in patients who need special nutrition through IV therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Hospital Juarez de Mexico Government |
| Locations | 1 site (Mexico City, Mexico City) |
| Trial ID | NCT06009744 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of different doses of vitamin C and zinc on the closure and recurrence of high-output enterocutaneous fistulas in patients requiring parenteral nutrition. Participants will be randomly assigned to receive either low or high doses of these micronutrients while their nutritional needs are met through parenteral therapy. The study will monitor various health markers and assess the safety and efficacy of the interventions over time. Data will be collected on demographic variables, anthropometric measurements, and biochemical markers to evaluate the outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with a first-time diagnosis of high-output enterocutaneous fistula requiring parenteral nutrition.
Not a fit: Patients on octreotide, receiving palliative care, or with certain medical conditions such as G6PD deficiency or hemochromatosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new nutritional strategy to enhance the healing of enterocutaneous fistulas.
How similar studies have performed: While the specific combination of vitamin C and zinc for this condition is novel, similar studies have shown that micronutrients can play a significant role in wound healing.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Mexico City, Mexico City
- Hospital Juárez de México — Mexico City, Mexico City, Mexico (Recruiting)
Study contacts
- Principal investigator: Elizabeth Pérez Cruz — Hospital Juarez de Mexico
- Study coordinator: Elizabeth Pérez Cruz
- Email: pece_liz@hotmail.com
- Phone: 525557477560
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.