The Role of Cobamamide Supplements in Malnourished Patients

NCT ID: NCT05944744

Last Updated: 2023-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-31

Study Completion Date

2024-08-31

Brief Summary

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

Detailed Description

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Conditions

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Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Adenosylcobalamin

Intervention Type DRUG

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

Control

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Adenosylcobalamin

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Cobazim 3000

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Interbat Pharmaceuticals

UNKNOWN

Sponsor Role collaborator

Fakultas Kedokteran Universitas Indonesia

OTHER

Sponsor Role lead

Responsible Party

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Marcellus Simadibrata, Prof. PhD., SpPD, KGEH

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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22-10-1267

Identifier Type: -

Identifier Source: org_study_id

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