The Role of Cobamamide Supplements in Malnourished Patients

Fakultas Kedokteran Universitas Indonesia124 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

124

Conditions

Malnutrition

Interventions

AdenosylcobalaminDRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change of Appetite

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

Time frame: 28 days

Nutritional Status

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

Time frame: 28 days

Bioimpendance Analysis Result

Changes in Muscle Mass

Time frame: 28 days

Vitamin B12 (1)

Serum B12 Level

Time frame: 28 days

Vitamin B12 (2)

Methylmalonic Acid Level

Time frame: 28 days

Pre-albumin

Prealbumin Level

Time frame: 28 days

Laboratory result (1)

Serum ureum and creatinine level

Time frame: 28 days

Laboratory result (2)

ALT and AST level

Time frame: 28 days

Laboratory result (3)

Complete Blood Count

Time frame: 28 days

Data from ClinicalTrials.gov

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