Oral Versus Intramuscular Cobalamin to Treat Cobalamin Deficiency: Noninferiority Randomised Controlled Trial Pragmatic and Multi-center in the Primary Healthcare Setting (OB12 Project)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 284
- 试验地点
- 1
- 主要终点
- Change from Cobalamin level standardization
研究概览
简要总结
Objective: To determine the effectiveness of oral versus intramuscular Cobalamin (vitamin B12) by restore cobalamin parameter in blood at 8, 26 and 52 weeks in ≥ 65 aged patients with Cobalamin Deficiency.
Design: Noninferiority randomised controlled trial, pragmatic and multi-center in the primary healthcare setting (Madrid Region).
Participants: ≥ 65 aged patients with Cobalamin Deficiency. Patients give inform consent. Number of patients: 320 (160 each arm). Assignment: randomized simple (automatic system).
Variables. Main outcome variable: Cobalamin level standardization (yes/no). Secondary outcome variables: Adverse events. Adherence measurement of treatment. Health related quality of life questionnaire (Euroqol-5D). Satisfaction and preferences. Other variables: Gender. Age. Live alone. Vegetarian diet. Alcohols consume. Clinic Variables (symptoms and physical examination) and blood parameters. Drugs consume.
Causes of all losses and withdrawals. Number of patients (age and gender) who declined to participate.
All data (excluding patient identification data) will be record in an electronic database.
Intervention group: oral Optovite® B12 1000 gammas. Control group: idem intramuscular.
Analysis: Descriptive analysis (screening phase). Baseline comparison of the two intervention groups. Effect of cobalamin (main outcome variable). Security. Quality of life. Adherence measurement of treatment.
详细描述
Variables. Main outcome variable: Cobalamin level standardization (yes/no). Secondary outcome variables: Adverse events. Adherence measurement of treatment. Health related quality of life questionnaire (Euroqol-5D). Satisfaction and preferences. Other variables: Gender. Age. Live alone. Vegetarian diet. Alcohols consume. Clinic Variables (symptoms and physical examination) and blood parameters. Drugs consume.
Causes of all losses and withdrawals. Number of patients (age and gender) who declined to participate.
All data (excluding patient identification data) will be record in an electronic database.
Intervention group: oral Optovite® B12 1000 gammas. Control group: idem intramuscular.
Analysis: Descriptive analysis (screening phase). Baseline comparison of the two intervention groups. Effect of cobalamin (main outcome variable). Security. Quality of life. Adherence measurement of treatment.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 65 aged patients with Cobalamin Deficiency.
- •Patients give inform consent.
排除标准
- •Treatment with B12 (1 last year)
- •Neurologic or psychiatric pathologies
- •Folic acid < 2.3ng/ml ...
研究组 & 干预措施
oral Cobalamin (vitamin B12)
oral Cobalamin (vitamin B12)
干预措施: oral Cobalamin (vitamin B12) (Drug)
intramuscular Cobalamin (vitamin B12)
intramuscular Cobalamin (vitamin B12)
干预措施: intramuscular Cobalamin (vitamin B12) (Drug)
结局指标
主要结局
Change from Cobalamin level standardization
时间窗: 1 year
Change from Baseline in Cobalamin level at 52 weeks
次要结局
未报告次要终点
研究者
Esperanza Escortell
Principal Investigator
Gerencia de Atención Primaria, Madrid