The Role of Cobamamide Supplements in Malnourished Patients

University of Indonesia (UI)

Status: Not yet enrolling

Conditions: Malnutrition

Treatments: Drug: Placebo; Drug: Adenosylcobalamin

Study type: Interventional

Funder types: Other

Identifiers

NCT05944744

22-10-1267

Details and patient eligibility

About

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

Enrollment: 124 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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124 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

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

Treatment:

Drug: Adenosylcobalamin

Control

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo