NCT05944744

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 13, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

July 13, 2023

Status Verified

July 1, 2023

Enrollment Period

1 year

First QC Date

February 12, 2023

Last Update Submit

July 6, 2023

Conditions

Malnutrition

Outcome Measures

Primary Outcomes (9)

  • 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

Study Arms (2)

Intervention

EXPERIMENTAL

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

Drug: Adenosylcobalamin

Control

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

AdenosylcobalaminDRUG

The drug contains Cobamamide / Adenosylcobalamin with dose of 3000 mg.

Also known as: Cobazim 3000
Intervention
PlaceboDRUG

The drug doesn't contain any properties or substances for treatment.

Control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • Diagnosis of malnutrition based on 2019 GLIM criteria
  • Participant agree to join the trial by signing infomed consent.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Malnutrition

Interventions

cobamamide

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 12, 2023

First Posted

July 13, 2023

Study Start

July 1, 2023

Primary Completion

July 1, 2024

Study Completion

August 1, 2024

Last Updated

July 13, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share