ClinicalTrials.gg
Not yet recruitingNCT05944744Updated Jul 13, 2023

The Role of Cobamamide Supplements in Malnourished Patients

An interventional study of Adenosylcobalamin and Placebo in Malnutrition, sponsored by Fakultas Kedokteran Universitas Indonesia. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-07-13.

Sponsored by Fakultas Kedokteran Universitas Indonesia · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
124
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Malnutrition

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03

In context

Malnutrition

1,277 studies on the registry are indexed under Malnutrition; 230 are open to participants now.

This study's planned enrollment of 124 is close to the median of 118 across 843 interventional studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

Fakultas Kedokteran Universitas Indonesia is the lead sponsor of 36 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • ( 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
124 participants (estimated)

Study arms

  • Experimental
    Intervention

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

    Drug: Adenosylcobalamin

  • Placebo comparator
    Control

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

    Drug: Placebo

Interventions

  • DrugAdenosylcobalamin

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

    Also known as: Cobazim 3000

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  1. Change of Appetite

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

    Time frame: 28 days

  2. Nutritional Status

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

    Time frame: 28 days

  3. Bioimpendance Analysis Result

    Changes in Muscle Mass

    Time frame: 28 days

  4. Vitamin B12 (1)

    Serum B12 Level

    Time frame: 28 days

  5. Vitamin B12 (2)

    Methylmalonic Acid Level

    Time frame: 28 days

  6. Pre-albumin

    Prealbumin Level

    Time frame: 28 days

  7. Laboratory result (1)

    Serum ureum and creatinine level

    Time frame: 28 days

  8. Laboratory result (2)

    ALT and AST level

    Time frame: 28 days

  9. Laboratory result (3)

    Complete Blood Count

    Time frame: 28 days

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05944744
Lead sponsor
Fakultas Kedokteran Universitas Indonesia
Collaborators
Interbat Pharmaceuticals
Responsible party
Marcellus Simadibrata, Prof. PhD., SpPD, KGEH (Professor, Fakultas Kedokteran Universitas Indonesia) — Principal investigator
First posted
Jul 13, 2023
Start date
Jul 2023 (estimated)
Primary completion
Jul 2024 (estimated)
Completion
Aug 2024 (estimated)
Last update
Jul 13, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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