Clinical trial
The Role of Cobamamide Supplements in Malnourished Patients
Name
22-10-1267
Description
The trial is conducted to observe the effectiveness of cobamamide supplements in improving the clinical state malnourished patients.
Trial arms
Trial start
2023-07-01
Estimated PCD
2024-07-01
Trial end
2024-08-01
Status
Not yet recruiting
Treatment
Adenosylcobalamin
The drug contains Cobamamide / Adenosylcobalamin with dose of 3000 mg.
Arms:
Intervention
Other names:
Cobazim 3000
Placebo
The drug doesn't contain any properties or substances for treatment.
Arms:
Control
Size
124
Primary endpoint
Change of Appetite
28 days
Nutritional Status
28 days
Bioimpendance Analysis Result
28 days
Vitamin B12 (1)
28 days
Vitamin B12 (2)
28 days
Pre-albumin
28 days
Laboratory result (1)
28 days
Laboratory result (2)
28 days
Laboratory result (3)
28 days
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 124, 'type': 'ESTIMATED'}}
Updated at
2023-07-13
1 organization
Organization
Faculty of Medicine University of Indonesia