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首页> 外文期刊>BMC Public Health >Oral versus intramuscular administration of vitamin B12 for the treatment of patients with vitamin B12 deficiency: a pragmatic, randomised, multicentre, non-inferiority clinical trial undertaken in the primary healthcare setting (Project OB12)
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Oral versus intramuscular administration of vitamin B12 for the treatment of patients with vitamin B12 deficiency: a pragmatic, randomised, multicentre, non-inferiority clinical trial undertaken in the primary healthcare setting (Project OB12)

机译：口服与肌肉内给药维生素B12来治疗维生素B12缺乏症的患者：在初级医疗机构中进行的一项实用，随机，多中心，非劣效性临床试验（OB12项目）

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Background The oral administration of vitamin B12 offers a potentially simpler and cheaper alternative to parenteral administration, but its effectiveness has not been definitively demonstrated. The following protocol was designed to compare the effectiveness of orally and intramuscularly administered vitamin B12 in the treatment of patients ≥65?years of age with vitamin B12 deficiency. Methods/design The proposed study involves a controlled, randomised, multicentre, parallel, non-inferiority clinical trial lasting one year, involving 23 primary healthcare centres in the Madrid region (Spain), and patients ≥65 years of age. The minimum number of patients required for the study was calculated as 320 (160 in each arm). Bearing in mind an estimated 8-10% prevalence of vitamin B12 deficiency among the population of this age group, an initial sample of 3556 patients will need to be recruited. Eligible patients will be randomly assigned to one of the two treatment arms. In the intramuscular treatment arm, vitamin B12 will be administered as follows: 1?mg on alternate days in weeks 1 and 2, 1?mg/week in weeks 3–8,and 1?mg/month in weeks 9–52. In the oral arm, the vitamin will be administered as: 1?mg/day in weeks 1–8 and 1?mg/week in weeks 9–52. The main outcome variable to be monitored in both treatment arms is the normalisation of the serum vitamin B12 concentration at weeks 8, 26 and 52; the secondary outcome variables include the serum concentration of vitamin B12 (in pg/ml), adherence to treatment, quality of life (EuroQoL-5D questionnaire), patient 3satisfaction and patient preferences. All statistical tests will be performed with intention to treat and per protocol. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in analyses. Discussion The results of this study should help establish, taking quality of life into account, whether the oral administration of vitamin B12 is an effective alternative to its intramuscular administration. If this administration route is effective, it should provide a cheaper means of treating vitamin B12 deficiency while inducing fewer adverse effects. Having such an alternative would also allow patient preferences to be taken into consideration at the time of prescribing treatment. Trial registration This trial has been registered with ClinicalTrials.gov, number NCT 01476007, and under EUDRACT number 2010-024129-20.
机译：背景技术维生素B12的口服给药是肠胃外给药的一种可能更简单，更便宜的替代方法，但尚未明确证明其有效性。以下方案旨在比较口服和肌肉内施用维生素B12在治疗65岁以上维生素B12缺乏症的患者中的有效性。方法/设计拟议的研究涉及一项持续一年的对照，随机，多中心，平行，非劣效性临床试验，涉及马德里地区（西班牙）的23个主要医疗中心以及≥65岁的患者。该研究所需的最少患者数经计算为320（每组160）。考虑到该年龄段人群中维生素B12缺乏症的患病率估计为8-10％，因此需要招募3556名患者的初始样本。符合条件的患者将被随机分配到两个治疗组之一。在肌肉内治疗组中，维生素B12的给药方式如下：在第1周和第2周的隔日服用1mg，在第3-8周的每周1mg / mg，在第9-52周的每月1mg / mg。在口服组中，维生素的给药方式为：第1-8周1天/毫克，第9-52周1天/毫克。在两个治疗组中要监测的主要结果变量是在第8、26和52周时血清维生素B12浓度的正常化。次要结果变量包括维生素B12的血清浓度（以pg / ml为单位），对治疗的依从性，生活质量（EuroQoL-5D调查问卷），患者3的满意度和患者的喜好。所有统计测试均将按照治疗方案进行处理。具有随机效应的逻辑回归将用于调整预后因素。分析中将考虑混杂因素或可能改变记录效果的因素。讨论这项研究的结果应有助于考虑生活质量，确定口服维生素B12是否能代替肌肉注射有效。如果该给药途径有效，则应提供一种更便宜的方法来治疗维生素B12缺乏症，同时减少副作用。拥有这样的替代方案还可以在开药时考虑患者的喜好。试验注册该试验已在ClinicalTrials.gov上注册，编号为NCT 01476007，并在EUDRACT编号为2010-024129-20下注册。

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