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临床试验/NCT01070446
NCT01070446已完成不适用

Choline Nutrition in Children With Cystic Fibrosis

University of British Columbia1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2007年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
plasma choline, SAM, SAM/SAH ratio, homocysteine, GSH and the GSH/GSSG

研究概览

简要总结

Cystic fibrosis (CF) is the most common lethal, inherited disorder among Caucasians. Choline is an essential vitamin and as a methyl donor is critically needed to support the normal metabolism. Our previous studies have demonstrated that children with CF have depleted levels of choline. The purpose of this study is to supply a choline supplement to children with CF to see if their nutrition and methyl status can be improved.

详细描述

This will be a prospective, repeated measures study involving 34 children with CF who will take a supplement of water soluble choline bitartrate, 2 gm/day with meals for 6 months. The baseline (day 0) results for each child will serve as his/her own control, and assessments will be made at 3 months and 6 months choline supplementation and again 3 months after stopping choline.

The supplement will be provided as capsules containing 250 mg choline bitartrate. 4 capsules will be taken with or immediately before each of two meals per day: breakfast and dinnertime meals, providing 1 gm of supplemental choline each day.

The children will be enrolled by description of the project to the child and their parent(s) at a CF clinic appointment. Body weight, height and blood pressure will be measured and routine blood work including liver enzymes, hematology, serum zinc, selenium and vitamins A and E will be completed as part of the clinic appointment. The hematology and clinical chemistry will be done by the Hematopathology and Clinical Chemistry labs at the B.C.'s Children's Hospital. CF genotype, gender, birth date, hematology, clinical chemistry, anthropometry, nutritional measures, pulmonary function test results, chest X-Ray and/or CT scans, pancreatic function test results (fecal elastase, chymotrypsin or secretin-CCK), medications and supplements (including enzymes, vitamins, minerals, nutrition supplements & Natural Health Products) and where available, liver ultrasound and biopsy reports will be collected from chart data. Information in the subject's medical charts relating to antibiotic therapy, duration of illnesses, hospitalization and diagnosis will be reviewed to ensure the inclusion/exclusion criteria are met.

Assessment of pulmonary function by computer assisted spirometry which includes the measures of forced vital capacity (FVC), forced expiratory volume in one second (FEV1) and forced mid-expiratory flow (FEF 25-75) is completed for all children as part of each regularly scheduled clinic visit and the results collected for this study.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
5 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children aged 5-17 yr with proven CF and known genotype
  • with stable pulmonary disease, are outpatients with no hospitalizations or changes to antibiotic regiment during the previous 1 month and not receiving any parenteral nutrition
  • are non-smokers without asthma, may be taking routine fat soluble vitamins but must not be taking any supplemental fish oil, docosahexanoic acid (DHA) or choline containing compounds, experimental drugs or any aerosol or oral interventions designed to deliver or increase glutathione or receiving oral or parenteral corticosteroidal medications. E.g prednisone.

排除标准

  • are not 5-17 years of age, do not have CF or have the medical condition trimethylaminuria.
  • have CF, but have allergies to any of the ingredients in the choline supplements; are hospitalized; have asthma or are smokers; are taking oral or parenteral corticosteroidal medications or any intravenous nutritional support; have kidney or liver disease; or have a baseline FEV 1 of less than 50% predicted value (which at our clinic means they are likely hospitalized or about to be admitted to hospital).

结局指标

主要结局

plasma choline, SAM, SAM/SAH ratio, homocysteine, GSH and the GSH/GSSG

时间窗: 9 months

次要结局

  • (2-hydroxyethyl) trimethylammonium salt (1:1)(9 months)

研究者

申办方类型
Other

研究点 (1)

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