Enterocutaneous FistulasVITACNCT06009744
Vitamin C and Zinc in Patients With Enterocutaneous Fistulas.
A study testing Low-dose vitamin C and zinc and High-dose vitamin C and zinc in people with Enterocutaneous Fistulas, run by Hospital Juarez de Mexico at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Enterocutaneous Fistulas
- What is being tested?
- Low-dose vitamin C and zinc and High-dose vitamin C and zinc
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteMexico
- Study dates
- Aug 2023to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women and men
- >18 years and <70 years old.
- Diagnosis of high-output enterocutaneous fistula for the first time
- Need for parenteral nutrition
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Hospital Juárez de México
Mexico City, Mexico City, 07760
Elizabeth PEREZ-CRUZ, MD, 5557477560 ext. 7497, pece_liz@yahoo.com.mx
About this study
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.
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.
Read the 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.
- Conditions
- Enterocutaneous Fistulas
- Being tested
- Low-dose vitamin C and zinc, High-dose vitamin C and zinc
- Keywords
- enterocutaneous fistulas, Vitamin C, Zinc, Parenteral nutrition
- Medical subject headings
- Intestinal Fistula, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose vitamin C and zincDrug
Also called Low Vit C y 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 zincDrug
Also called High Vit C y 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
| Study group | Role | What they receive |
|---|---|---|
| Vit C y zinc bajo | Sham comparator | Parenteral nutrition + Vitamin C 100-300 mg/d y zinc 3-5 mg/d Receives: 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 Receives: Drug: High-dose vitamin C and zinc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fistula closure
Evaluate enterocutaneous fistula closure rate.
Measured: follow-up at 30 days
Recurrence of fistula
Evaluate the recurrence of enterocutaneous fistula
Measured: follow-up at 30 days
Secondary outcomes (9)
Medical-nutritional status
Medical-nutritional status: subjective global assessment
Measured: 24-72 hours after hospital admission
Medical-nutritional status
Medical-nutritional status: nutritional risk index
Measured: 24-72 hours after hospital admission
biochemical markers
Changes in nutritional status biochemical markers: albumin in serum
Measured: every week until a maximum follow-up at 30 days
biochemical markers
Changes in nutritional status biochemical markers: lymphocytes in serum.
Measured: every week until a maximum follow-up at 30 days
biochemical markers
Changes in nutritional status biochemical markers: prealbumin in serum.
Measured: every week until a maximum follow-up at 30 days
biochemical markers
Changes in nutritional status biochemical markers: transferrin in serum.
Measured: every week until a maximum follow-up at 30 days
Metabolic profile
Changes in metabolic profile in serum glucose concentration
Measured: every week until a maximum follow-up at 30 days
Metabolic profile
Changes in metabolic profile in serum tests liver
Measured: every 15 days up to a maximum follow-up at 30 days
Length of hospital stay of patients
Determine the length of hospital stay of patients.
Measured: follow-up at 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study startAug 2023 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Enterocutaneous FistulasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Juarez de Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, ELIZABETH PEREZ CRUZ, Hospital Juarez de Mexico
- Investigators
- Elizabeth Pérez Cruz, Principal investigator, Hospital Juarez de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009744
- Sponsor's protocol ID
- HJM 005/32-I
- Acronym
- VITAC
- Status last verified
- Aug 2023
- First submitted
- 16 Jul 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19874952Yanase 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.
PubMed 32404636Couper 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.
PubMed 33368576Weimann 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.
PubMed 28385477Girard 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.
PubMed 25455960
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06009744
- Acronym / sponsor ID
- VITAC / HJM 005/32-I
- Conditions
- Enterocutaneous Fistulas
- Keywords
- enterocutaneous fistulas, Vitamin C, Zinc, Parenteral nutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Hospital Juarez de MexicoOther government
- Study start
- Aug 2023 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 24 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Vit C y zinc bajo | Sham comparator | Drug: Low-dose vitamin C and zincParenteral nutrition + Vitamin C 100-300 mg/d y zinc 3-5 mg/d |
| Vit C and zinc alto | Active comparator | Drug: High-dose vitamin C and zincParenteral nutrition + Vitamin C 1000-2000 mg/d y zinc 10-15 mg/d |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women and men
- >18 years and <70 years old.
- Diagnosis of high-output enterocutaneous fistula for the first time
- Need for parenteral nutrition
Key exclusion criteria (8 listed)
- Octreotide use
- Palliative care
- Steroid use
- Oxalate nephropathy
- G6PD deficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose vitamin C and zincAlso: Low Vit C y zincThis 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 | Drug | Vit C y zinc bajo |
| High-dose vitamin C and zincAlso: High Vit C y zincThis 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 | Drug | Vit C and zinc alto |
Primary outcome
Fistula closure
Time frame: follow-up at 30 days
Evaluate enterocutaneous fistula closure rate.
Recurrence of fistula
Time frame: follow-up at 30 days
Evaluate the recurrence of enterocutaneous fistula
9 secondary outcomes
Medical-nutritional status
Time frame: 24-72 hours after hospital admission
Medical-nutritional status
Time frame: 24-72 hours after hospital admission
biochemical markers
Time frame: every week until a maximum follow-up at 30 days
biochemical markers
Time frame: every week until a maximum follow-up at 30 days
biochemical markers
Time frame: every week until a maximum follow-up at 30 days
biochemical markers
Time frame: every week until a maximum follow-up at 30 days
Metabolic profile
Time frame: every week until a maximum follow-up at 30 days
Metabolic profile
Time frame: every 15 days up to a maximum follow-up at 30 days
Length of hospital stay of patients
Time frame: follow-up at 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Background: PubMed 19874952Jeejeebhoy 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.
- Background: PubMed 32404636Yanase 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.
- Background: PubMed 33368576Couper 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.
- Background: PubMed 28385477Weimann 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.
- Background: PubMed 25455960Girard 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth Pérez Cruz principal investigator
Hospital Juarez de Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-dose vitamin C and zinc and High-dose vitamin C and zinc in people with Enterocutaneous Fistulas, run by Hospital Juarez de Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Pérez Cruz (525557477560 ext. 7497, pece_liz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fistula closure (time frame: follow-up at 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06009744, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.