The Role of Cobamamide Supplements in Malnourished Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 124
- 主要终点
- Vitamin B12 (2)
研究概览
简要总结
The trial is conducted to observe the effectiveness of cobamamide supplements in improving the clinical state malnourished patients.
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, Investigator)
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
- •18 - 70 years old
- •Diagnosis of malnutrition based on 2019 GLIM criteria
- •Participant agree to join the trial by signing infomed consent.
排除标准
- •Malignancy (ECOG IV) and bowel obstruction
- •Patients who unable to tolerate oral intake and in total parenteral nutrition
- •Bowel disorder that caused severe malabsorbtion
- •Patients who refuse to join the trial
研究组 & 干预措施
Intervention
The patient is given Cobamamide 2 x 3000 mg for 28 days.
干预措施: Adenosylcobalamin (Drug)
Control
The patient is given placebo 2 x 1 capsule for 28 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Vitamin B12 (2)
时间窗: 28 days
Methylmalonic Acid Level
Laboratory result (2)
时间窗: 28 days
ALT and AST level
Laboratory result (3)
时间窗: 28 days
Complete Blood Count
Change of Appetite
时间窗: 28 days
Using the Council on Nutrition Appetite Questionnaire to evaluate the appettite changes
Nutritional Status
时间窗: 28 days
Using the Subjective Global Asssessment form to assess the changes in nutritional status
Vitamin B12 (1)
时间窗: 28 days
Serum B12 Level
Pre-albumin
时间窗: 28 days
Prealbumin Level
Laboratory result (1)
时间窗: 28 days
Serum ureum and creatinine level
Bioimpendance Analysis Result
时间窗: 28 days
Changes in Muscle Mass
次要结局
未报告次要终点
研究者
Marcellus Simadibrata, Prof. PhD., SpPD, KGEH
Professor
Fakultas Kedokteran Universitas Indonesia