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StrokeNCT04259307

Effect of Intensive Nutritional Support in Subacute Stroke Patient

A study testing Omapone Peri 724mL or Winuf Peri 654mL in people with Stroke and Rehabilitation, run by Samsung Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Proper nutritional support during early rehabilitation may be beneficial for functional improvements in gaining functional independence and preventing complications in stroke patients. However, there was no consensus of proper amount of nutritional support in stroke patients. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Stroke, Rehabilitation, Nutrition
What is being tested?
Omapone Peri 724mL or Winuf Peri 654mL
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
97 participants
Where
1 siteSouth Korea
Study dates
29 Jan 2020to 31 Dec 2023
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Acute first-ever stroke patients less than 7 days after onset
  • more than 19 years old at stroke onset ③ stroke confirmed by brain CT or MRI
  • body mass index (BMI) <25 before the comprehensive rehabilitation ⑤ Mini Nutritional Assessment < 12 before the comprehensive rehabilitation ⑥ Fugl-Meyer assessment < 85 at 7 days after stroke onset

Who cannot join

  • Transient ischemic stroke
  • Progressive or unstable stroke
  • Pre-existing and active major neurological disease, e.g., spinal cord injury, Parkinson's disease, et al.
  • Pre-existing and active (e.g., on chronic medication) major psychiatric disease, such as major depression, schizophrenia, bipolar disease or dementia ⑤ Advanced liver, kidney, cardiac, or pulmonary disease, e.g., advanced hepatocellular carcinoma, end-stage renal failure, et al.)
  • A terminal medical diagnosis consistent with survival < 1 year
  • Diabetes mellitus, Hyperlipidemia, Metabolic syndrome, Heart failure) ⑧ Pregnant or lactating women ⑨ Prohibited from taking medication (Omapone Peri 724mL or Winuf Peri 654mL)

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Samsung Medical Center

    Seoul, 135-710

Other trials in South Korea

About this study

Official title: Effect of Intensive Nutritional Support on Functional Recovery in Subacute Stroke Patient

Proper nutritional support during early rehabilitation may be beneficial for functional improvements in gaining functional independence and preventing complications in stroke patients. However, there was no consensus of proper amount of nutritional support in stroke patients. In this study, the investigators aimed to clarigy the effects of the intensive nutritional support during comprehensive rehabilitation during subacute phase to improve function in patients with first-ever strokes.

Being tested
Omapone Peri 724mL or Winuf Peri 654mL
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Omapone Peri 724mL or Winuf Peri 654mLDrug

    Also called Comprehensive rehabilitation

    Additional intravenous nutrition of 500 kcal per day for 3 weeks

Study groups in NCT04259307
Study groupRoleWhat they receive
Intensive nutrition groupExperimentalStandard nutritional support with additional intravenous nutrition of 500 kcal per day for 3 weeks
Receives: Drug: Omapone Peri 724mL or Winuf Peri 654mL
Control groupNo interventionStandard nutritional support only per day for 3 weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Korean modified Barthel Index (K-MBI) at 6 months after onset

    Korean modified Barthel Index (0~100)

    Measured: 6 months after onset

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2020
  2. Study start29 Jan 2020
  3. Primary completion31 Aug 2023
  4. Study completion31 Dec 2023

Resources

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
Outcomes assessor
Enrolment
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04259307
Sponsor's protocol ID
2019-06-109
Status last verified
Mar 2024
First submitted
4 Feb 2020
Last updated
7 Mar 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kim DH, Sohn MK, Lee J, Kim DY, Shin YI, Oh GJ, Lee YS, Joo MC, Lee SY, Song MK, Han J, Ahn J, Lee HS, Kim YT, Kim YH, Chang WH. Effect of intensive nutritional support on functional recovery in subacute stroke: A randomized, multicenter, single-blinded trial. Ann Phys Rehabil Med. 2025 May;68(4):101976. doi: 10.1016/j.rehab.2025.101976. Epub 2025 Apr 17.

    PubMed 40250062

Questions about this trial

What is this clinical trial studying?

A study testing Omapone Peri 724mL or Winuf Peri 654mL in people with Stroke and Rehabilitation, run by Samsung Medical Center at 1 site in South Korea.

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 6 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: finished, as of the sponsor's last update on 7 Mar 2024. 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 South Korea. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Korean modified Barthel Index (K-MBI) at 6 months after onset (time frame: 6 months after onset). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04259307, which also lists 1 linked publication.

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 7 Mar 2024.

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