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The Role of Cobamamide Supplements in Malnourished Patients

Primary Purpose

Malnutrition

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Adenosylcobalamin
Placebo
Sponsored by
Fakultas Kedokteran Universitas Indonesia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Intervention

    Control

    Arm Description

    The patient is given Cobamamide 2 x 3000 mg for 28 days.

    The patient is given placebo 2 x 1 capsule for 28 days.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    February 12, 2023
    Last Updated
    July 6, 2023
    Sponsor
    Fakultas Kedokteran Universitas Indonesia
    Collaborators
    Interbat Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05944744
    Brief Title
    The Role of Cobamamide Supplements in Malnourished Patients
    Official Title
    The Role of Cobamamide Supplements in Malnourished Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    July 2024 (Anticipated)
    Study Completion Date
    August 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fakultas Kedokteran Universitas Indonesia
    Collaborators
    Interbat Pharmaceuticals

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malnutrition

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    124 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    The patient is given Cobamamide 2 x 3000 mg for 28 days.
    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    The patient is given placebo 2 x 1 capsule for 28 days.
    Intervention Type
    Drug
    Intervention Name(s)
    Adenosylcobalamin
    Other Intervention Name(s)
    Cobazim 3000
    Intervention Description
    The drug contains Cobamamide / Adenosylcobalamin with dose of 3000 mg.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    The drug doesn't contain any properties or substances for treatment.
    Primary Outcome Measure Information:
    Title
    Change of Appetite
    Description
    Using the Council on Nutrition Appetite Questionnaire to evaluate the appettite changes
    Time Frame
    28 days
    Title
    Nutritional Status
    Description
    Using the Subjective Global Asssessment form to assess the changes in nutritional status
    Time Frame
    28 days
    Title
    Bioimpendance Analysis Result
    Description
    Changes in Muscle Mass
    Time Frame
    28 days
    Title
    Vitamin B12 (1)
    Description
    Serum B12 Level
    Time Frame
    28 days
    Title
    Vitamin B12 (2)
    Description
    Methylmalonic Acid Level
    Time Frame
    28 days
    Title
    Pre-albumin
    Description
    Prealbumin Level
    Time Frame
    28 days
    Title
    Laboratory result (1)
    Description
    Serum ureum and creatinine level
    Time Frame
    28 days
    Title
    Laboratory result (2)
    Description
    ALT and AST level
    Time Frame
    28 days
    Title
    Laboratory result (3)
    Description
    Complete Blood Count
    Time Frame
    28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Role of Cobamamide Supplements in Malnourished Patients

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