The Role of Cobamamide Supplements in Malnourished Patients

Malnutrition Clinical Trial

Official title:

The Role of Cobamamide Supplements in Malnourished Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05944744
• Other study ID #: 22-10-1267
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2023
• Est. completion date: August 2024

Study information

• Verified date: July 2023
• Source: Fakultas Kedokteran Universitas Indonesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 124
• Est. completion date: August 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition

Intervention

Drug:
• Adenosylcobalamin
The drug contains Cobamamide / Adenosylcobalamin with dose of 3000 mg.
• Placebo
The drug doesn't contain any properties or substances for treatment.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Fakultas Kedokteran Universitas Indonesia	Interbat Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Appetite	Using the Council on Nutrition Appetite Questionnaire to evaluate the appettite changes	28 days
Primary	Nutritional Status	Using the Subjective Global Asssessment form to assess the changes in nutritional status	28 days
Primary	Bioimpendance Analysis Result	Changes in Muscle Mass	28 days
Primary	Vitamin B12 (1)	Serum B12 Level	28 days
Primary	Vitamin B12 (2)	Methylmalonic Acid Level	28 days
Primary	Pre-albumin	Prealbumin Level	28 days
Primary	Laboratory result (1)	Serum ureum and creatinine level	28 days
Primary	Laboratory result (2)	ALT and AST level	28 days
Primary	Laboratory result (3)	Complete Blood Count	28 days