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The Role of Cobamamide Supplements in Malnourished Patients

Sponsor
Fakultas Kedokteran Universitas Indonesia (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05944744
Collaborator
Interbat Pharmaceuticals (Other)
124
Enrollment
2
Arms
13
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
124 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
The Role of Cobamamide Supplements in Malnourished Patients
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Change of Appetite [28 days]

      Using the Council on Nutrition Appetite Questionnaire to evaluate the appettite changes

    2. Nutritional Status [28 days]

      Using the Subjective Global Asssessment form to assess the changes in nutritional status

    3. Bioimpendance Analysis Result [28 days]

      Changes in Muscle Mass

    4. Vitamin B12 (1) [28 days]

      Serum B12 Level

    5. Vitamin B12 (2) [28 days]

      Methylmalonic Acid Level

    6. Pre-albumin [28 days]

      Prealbumin Level

    7. Laboratory result (1) [28 days]

      Serum ureum and creatinine level

    8. Laboratory result (2) [28 days]

      ALT and AST level

    9. Laboratory result (3) [28 days]

      Complete Blood Count

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Fakultas Kedokteran Universitas Indonesia
    • Interbat Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marcellus Simadibrata, Prof. PhD., SpPD, KGEH, Professor, Fakultas Kedokteran Universitas Indonesia
    ClinicalTrials.gov Identifier:
    NCT05944744
    Other Study ID Numbers:
    • 22-10-1267
    First Posted:
    Jul 13, 2023
    Last Update Posted:
    Jul 13, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Malnutrition

    Study Results

    No Results Posted as of Jul 13, 2023