The Role of Cobamamide Supplements in Malnourished Patients
Not Applicable
Not yet recruiting
- Conditions
- Malnutrition
- Interventions
- Drug: Placebo
- Registration Number
- NCT05944744
- Lead Sponsor
- Fakultas Kedokteran Universitas Indonesia
- Brief Summary
The trial is conducted to observe the effectiveness of cobamamide supplements in improving the clinical state malnourished patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 124
Inclusion Criteria
- 18 - 70 years old
- Diagnosis of malnutrition based on 2019 GLIM criteria
- Participant agree to join the trial by signing infomed consent.
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Placebo The patient is given placebo 2 x 1 capsule for 28 days. Intervention Adenosylcobalamin The patient is given Cobamamide 2 x 3000 mg for 28 days.
- Primary Outcome Measures
Name Time Method Vitamin B12 (2) 28 days Methylmalonic Acid Level
Laboratory result (2) 28 days ALT and AST level
Laboratory result (3) 28 days Complete Blood Count
Change of Appetite 28 days Using the Council on Nutrition Appetite Questionnaire to evaluate the appettite changes
Nutritional Status 28 days Using the Subjective Global Asssessment form to assess the changes in nutritional status
Vitamin B12 (1) 28 days Serum B12 Level
Pre-albumin 28 days Prealbumin Level
Laboratory result (1) 28 days Serum ureum and creatinine level
Bioimpendance Analysis Result 28 days Changes in Muscle Mass
- Secondary Outcome Measures
Name Time Method