MalnutritionNCT04036825
Liquid Nutritional Supplement on Malnutrition Hospitalized Patient
A study testing Liquid Nutritional Supplement from Hospital Product in people with Malnutrition, run by Fakultas Kedokteran Universitas Indonesia at 1 site in Indonesia.
Trial summary
The aim of this study is to know the effectivity of liquid nutritional supplementation in malnutrition hospitalized patients Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Malnutrition
- What is being tested?
- Liquid Nutritional Supplement from Hospital Product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 1 siteIndonesia
- Study dates
- Aug 2019to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- aged ≥ 18 years old to 60 years old
- malnutrition hospitalized patient based on European Society for Clinical Nutrition and Metabolism (ESPEN) 2015 criteria
- agreed to participate
Who cannot join
- malignancy
- chronic kidney disease stage III-V
- decompensated hepatic cirrhosis
- allergic to milk or lactose intolerance
- could not be randomised and participate in this study by clinical judgement
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)
Jakarta Pusat, 10430
Marcellus Simadibrata, 0816920448, marcellussimadibrata57@gmail.com
About this study
Official title: Effectivity of Liquid Nutritional Supplementation in Improving Nutritional Status of Hospitalized Malnutrition Patients: A Single-Blind Randomized Controlled Trial
The aim of this study is to know the effectivity of liquid nutritional supplementation in malnutrition hospitalized patients
- Conditions
- Malnutrition
- Being tested
- Liquid Nutritional Supplement from Hospital Product, Placebo
- Keywords
- Liquid Nutritional Supplement
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid Nutritional Supplement from Hospital ProductDietary supplement
Liquid Nutritional Supplement from Hospital Product is given 2 times daily for 14 days
PlaceboDietary supplement
Standard nutritional supplement is given 2 times daily as placebo for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Liquid Nutritional Supplement from Hospital Product | Experimental | This group received liquid nutritional supplement from hospital product. The product is in a form of low lactose milk ready to drink with volume 200 ml and will be given 2 times daily for 14 days. This product is consist of 1.017 kcal/ml, 10 vitamin and 9 mineral Receives: Dietary Supplement: Liquid Nutritional Supplement from Hospital Product |
| Placebo | Placebo comparator | This group received standard liquid nutritional supplement as a placebo. Placebo will be given 2 times daily for 14 days Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Body Mass Index (BMI)
BMI was assessed from height and body calculation. Classification of BMI is based on World Health Organization (WHO) classification.
Measured: 0 and 14 days
Secondary outcomes (8)
Change of Subjective Global Assessment (SGA) rank
SGA rank is classified to A (well nourished), B (moderately malnourished) and C (severely malnourished) and these option are chosen based on history and physical examination that are stated in the SGA form.
Measured: 0 and 14 days
Change of body fat percentage
Body fat percentage is assessed by Bioelectrical Impedance Analysis (BIA)
Measured: 0 and 14 days
Change of handgrip strength test score
Handgrip strength is assessed by handgrip strength score.
Measured: 0 and 14 days
Change of hemoglobin level
Hemoglobin level is obtain from laboratory test
Measured: 0 and 14 days
Change of prealbumin level
Prealbumin level is obtain from laboratory test
Measured: 0 and 14 days
Change of Blood Urea Nitrogen (BUN) level
BUN level is obtain from laboratory test
Measured: 0 and 14 days
Change of lipid profile level
Lipid profile level is obtain from laboratory test
Measured: 0 and 14 days
Change of blood glucose level
Blood glucose level is obtain from laboratory test
Measured: 0 and 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study startAug 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fakultas Kedokteran Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcellus Simadibrata, Prof. PhD., SpPD, KGEH, Fakultas Kedokteran Universitas Indonesia
- Investigators
- Marcellus Simadibrata, Principal investigator, Division Of Gastroenterology Department Of Internal Medicine Faculty Of Medicine Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036825
- Sponsor's protocol ID
- 19-01-0082
- Status last verified
- Aug 2019
- First submitted
- 25 Jul 2019
- Last updated
- 5 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectivity of Liquid Nutritional Supplementation in Improving Nutritional Status of Hospitalized Malnutrition Patients: A Single-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04036825
- Acronym / sponsor ID
- 19-01-0082
- Conditions
- Malnutrition
- Keywords
- Liquid Nutritional Supplement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Fakultas Kedokteran Universitas IndonesiaUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 30 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to know the effectivity of liquid nutritional supplementation in malnutrition hospitalized patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liquid Nutritional Supplement from Hospital Product | Experimental | Dietary Supplement: Liquid Nutritional Supplement from Hospital ProductThis group received liquid nutritional supplement from hospital product. The product is in a form of low lactose milk ready to drink with volume 200 ml and will be given 2 times daily for 14 days. This product is consist of 1.017 kcal/ml, 10 vitamin and 9 mineral |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThis group received standard liquid nutritional supplement as a placebo. Placebo will be given 2 times daily for 14 days |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- aged ≥ 18 years old to 60 years old
- malnutrition hospitalized patient based on European Society for Clinical Nutrition and Metabolism (ESPEN) 2015 criteria
- agreed to participate
Key exclusion criteria (5 listed)
- malignancy
- chronic kidney disease stage III-V
- decompensated hepatic cirrhosis
- allergic to milk or lactose intolerance
- could not be randomised and participate in this study by clinical judgement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liquid Nutritional Supplement from Hospital ProductLiquid Nutritional Supplement from Hospital Product is given 2 times daily for 14 days | Dietary supplement | Liquid Nutritional Supplement from Hospital Product |
| PlaceboStandard nutritional supplement is given 2 times daily as placebo for 14 days | Dietary supplement | Placebo |
Primary outcome
Change of Body Mass Index (BMI)
Time frame: 0 and 14 days
BMI was assessed from height and body calculation. Classification of BMI is based on World Health Organization (WHO) classification.
8 secondary outcomes
Change of Subjective Global Assessment (SGA) rank
Time frame: 0 and 14 days
Change of body fat percentage
Time frame: 0 and 14 days
Change of handgrip strength test score
Time frame: 0 and 14 days
Change of hemoglobin level
Time frame: 0 and 14 days
Change of prealbumin level
Time frame: 0 and 14 days
Change of Blood Urea Nitrogen (BUN) level
Time frame: 0 and 14 days
Change of lipid profile level
Time frame: 0 and 14 days
Change of blood glucose level
Time frame: 0 and 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcellus Simadibrata principal investigator
Division Of Gastroenterology Department Of Internal Medicine Faculty Of Medicine Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liquid Nutritional Supplement from Hospital Product in people with Malnutrition, run by Fakultas Kedokteran Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcellus Simadibrata (0816920448, marcellussimadibrata57@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Body Mass Index (BMI) (time frame: 0 and 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2019.