Malnutrition
Conditions
Brief summary
The trial is conducted to observe the effectiveness of cobamamide supplements in improving the clinical state malnourished patients.
Interventions
DRUGAdenosylcobalamin
The drug contains Cobamamide / Adenosylcobalamin with dose of 3000 mg.
DRUGPlacebo
The drug doesn't contain any properties or substances for treatment.
Sponsors
Interbat Pharmaceuticals
Fakultas Kedokteran Universitas Indonesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Bioimpendance Analysis Result | 28 days | Changes in Muscle Mass |
| Vitamin B12 (1) | 28 days | Serum B12 Level |
| Vitamin B12 (2) | 28 days | Methylmalonic Acid Level |
| Pre-albumin | 28 days | Prealbumin Level |
| Laboratory result (1) | 28 days | Serum ureum and creatinine level |
| Laboratory result (2) | 28 days | ALT and AST level |
| Laboratory result (3) | 28 days | Complete Blood Count |
Outcome results
None listed