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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Fistula closure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women and men
- •>18 years and <70 years old.
- •Diagnosis of high-output enterocutaneous fistula for the first time
- •Need for parenteral nutrition
排除标准
- •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
研究组 & 干预措施
Vit C y zinc bajo
Parenteral nutrition + Vitamin C 100-300 mg/d y zinc 3-5 mg/d
干预措施: Low-dose vitamin C and zinc (Drug)
Vit C and zinc alto
Parenteral nutrition + Vitamin C 1000-2000 mg/d y zinc 10-15 mg/d
干预措施: High-dose vitamin C and zinc (Drug)
结局指标
主要结局
Fistula closure
时间窗: follow-up at 30 days
Evaluate enterocutaneous fistula closure rate.
Recurrence of fistula
时间窗: follow-up at 30 days
Evaluate the recurrence of enterocutaneous fistula
次要结局
- Length of hospital stay of patients(follow-up at 30 days)
- biochemical markers(every week until a maximum follow-up at 30 days)
- Medical-nutritional status(24-72 hours after hospital admission)
- Metabolic profile(every 15 days up to a maximum follow-up at 30 days)
研究者
ELIZABETH PEREZ CRUZ
MD, MSc, Prof.
Hospital Juarez de Mexico