Hospital Juárez de México
Mexico City, 07760, Mexico
Location status: Recruiting
NCT Number: NCT06009744
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Mexico City, 07760, Mexico
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: follow-up at 30 days
Evaluate enterocutaneous fistula closure rate.
Time frame: follow-up at 30 days
Evaluate the recurrence of enterocutaneous fistula
Time frame: 24-72 hours after hospital admission
Medical-nutritional status: subjective global assessment
Time frame: 24-72 hours after hospital admission
Medical-nutritional status: nutritional risk index
Time frame: every week until a maximum follow-up at 30 days
Changes in nutritional status biochemical markers: albumin in serum
Time frame: every week until a maximum follow-up at 30 days
Changes in nutritional status biochemical markers: lymphocytes in serum.
Time frame: every week until a maximum follow-up at 30 days
Changes in nutritional status biochemical markers: prealbumin in serum.
Time frame: every week until a maximum follow-up at 30 days
Changes in nutritional status biochemical markers: transferrin in serum.
Time frame: every week until a maximum follow-up at 30 days
Changes in metabolic profile in serum glucose concentration
Time frame: every 15 days up to a maximum follow-up at 30 days
Changes in metabolic profile in serum tests liver
Time frame: follow-up at 30 days
Determine the length of hospital stay of patients.
Contact information is provided by the study sponsor or research team.
Elizabeth Pérez Cruz
CONTACT
525557477560 ext. 7497
Salvador Ortiz Gutiérrez
CONTACT
525557477560 ext. 7497
Hospital Juarez de Mexico
Other Gov
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
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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