The Role of Cobamamide Supplements in Malnourished Patients

The trial is conducted to observe the effectiveness of cobamamide supplements in improving the clinical state malnourished patients.

Study Overview

• Status: Not yet recruiting
• Conditions: Malnutrition
• Intervention / Treatment: Drug: Adenosylcobalamin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 124
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; The patient is given Cobamamide 2 x 3000 mg for 28 days.	Drug: Adenosylcobalamin; The drug contains Cobamamide / Adenosylcobalamin with dose of 3000 mg.; Other Names: Cobazim 3000
Placebo Comparator: Control; The patient is given placebo 2 x 1 capsule for 28 days.	Drug: Placebo; The drug doesn't contain any properties or substances for treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Appetite	Using the Council on Nutrition Appetite Questionnaire to evaluate the appettite changes	28 days
Nutritional Status	Using the Subjective Global Asssessment form to assess the changes in nutritional status	28 days
Bioimpendance Analysis Result	Changes in Muscle Mass	28 days
Vitamin B12 (1)	Serum B12 Level	28 days
Vitamin B12 (2)	Methylmalonic Acid Level	28 days
Pre-albumin	Prealbumin Level	28 days
Laboratory result (1)	Serum ureum and creatinine level	28 days
Laboratory result (2)	ALT and AST level	28 days
Laboratory result (3)	Complete Blood Count	28 days

Collaborators and Investigators

• Sponsor: Fakultas Kedokteran Universitas Indonesia
• Collaborators: Interbat Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: February 12, 2023
• First Submitted That Met QC Criteria: July 6, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: 22-10-1267

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No