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Recruiting NCT05066503

NCT05066503 Nutritional Therapy for Delirium in Elderly Hospitalized Subjects

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Clinical Trial Summary
NCT ID NCT05066503
Status Recruiting
Phase
Sponsor University of Arkansas
Condition Subacute Delirium
Study Type INTERVENTIONAL
Enrollment 60 participants
Start Date 2020-11-16
Primary Completion 2026-08

Eligibility & Interventions

Sex All sexes
Min Age 60 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
260279 active study product

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 60 participants in total. It began in 2020-11-16 with a primary completion date of 2026-08.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

The investigators have developed a proprietary blend of amino acids that they think will help to prevent or reduce the severity of delirium in older adults (60 years and older) who are hospitalized for certain infections. In this study, up to 60 people will be enrolled.20 will be asked to drink this blend twice a day for up to 4 days, and 20 will receive standard treatment in the hospital for the same time period. The other 20 subjects will be non-delirious control subjects who do not consume any study products.

Eligibility Criteria

Inclusion Criteria: Delirious cohort 1. Aged 60 years and older. 2. Documented presence of either delirium, acute confusion, or altered mental status in medical record. 3. Currently hospitalized with a diagnosis of one of the following: 1. sepsis/septicemia 2. Pneumonia 3. Urinary tract infection 4. Clostridium-difficile infection 5. Other bone or tissue infection 6. Fever of unknown origin Inclusion Criteria: NON-Delirious cohort 1. Aged 60 years and older. 2. Current diagnosis of one of the following: 1. sepsis/septicemia 2. Pneumonia 3. Urinary tract infection 4. Clostridium-difficile infection 5. Other bone or tissue infection 6. Fever of unknown origin Exclusion Criteria: all subjects 1. Chronic kidney disease (eGFR \<30). 2. Admitted to the hospital for major psychiatric illness. 3. Major psychiatric illness not controlled by medication/treatment. 4. Delirium etiology of drug overdose or alcohol withdrawal. 5. Major surgery within the past five days. 6. Known or suspected Covid-19 positive. 7. Continuous feeding tube

Contact & Investigator

Central Contact

Gohar Azhar, M.D.

✉ azhargohar@uams.edu

📞 5015265935

Principal Investigator

Gohar Azhar, M.D.

PRINCIPAL INVESTIGATOR

University of Arkansas

Frequently Asked Questions

Who can join the NCT05066503 clinical trial?

This trial is open to participants of all sexes, aged 60 Years or older, studying Subacute Delirium. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT05066503 currently recruiting?

Yes, NCT05066503 is actively recruiting participants. Contact the research team at azhargohar@uams.edu for enrollment information.

Where is the NCT05066503 trial being conducted?

This trial is being conducted at Little Rock, United States.

Who is sponsoring the NCT05066503 clinical trial?

NCT05066503 is sponsored by University of Arkansas. The principal investigator is Gohar Azhar, M.D. at University of Arkansas. The trial plans to enroll 60 participants.

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