Effect of an anti-inflammatory formula for Oral Nutrition Support (ONS) in critically ill patients admitted to the intensive care unit

Design and development of an anti-inflammatory formula for Oral Nutrition Support (ONS) and its effects on inflammatory markers, antioxidants status and clinical outcomes in critically ill patients admitted to the intensive care unit: A double blined randomized control trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210217050393N4

Enrollment

Registered

2023-08-05

Start date

2023-07-15

Completion date

Unknown

Last updated

2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: sepsis. Condition 2: Acute respiratory distress syndrome (ARDS). Condition 3: critically ill patients.

Interventions

Intervention 1: Intervention group: after determining the daily needs of the intervention group, 500 cc of the anti-inflammatory oral nutritional supplement (ONS) formula in 2 meals and in the form of

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age 65-18 years Normal Gastrointestinal function Having indication for enteral nutrition

Exclusion criteria

Exclusion criteria: Impossibility of enteral feeding in the first 48 hours of admission History of underlying advanced heart disease Patients who are hospitalized in the intensive care unit for less than 96 hours. Patients expected to die within 12 hours of admission to the intensive care unit. Patients who do not have an indication for enteral nutrition on the first day, and based on the diagnosis of the intensive care unit, it is confirmed and predicted that they will not be able to receive enteral nutrition in the future. Patients who are under nutritional support by complete Parenteral Nutrition. Patients who have a history of underlying disease such as uncontrolled diabetes, congenital and immune disorders, advanced kidney and liver failure, and pancreatitis. Lack of consent of the patients or their legal guardian

Design outcomes

Primary

Measure	Time frame
(hs-crp) Inflammatory factor. Timepoint: At baseline, day 7 and day 14. Method of measurement: ELISA kit.;ESR inflammatory factor. Timepoint: At baseline, day 7 and day 14. Method of measurement: ELISA kit.;TAC antioxidant factor. Timepoint: At baseline, day 7 and day 14. Method of measurement: ELISA kit.;MDA antioxidant factor. Timepoint: At baseline, day 7 and day 14. Method of measurement: ELISA kit.;SOFA disease severity measure. Timepoint: At baseline, day 7 and day 14. Method of measurement: SOFA score questionnaire.	—

Measure

Time frame

(hs-crp) Inflammatory factor. Timepoint: At baseline, day 7 and day 14. Method of measurement: ELISA kit.;ESR inflammatory factor. Timepoint: At baseline, day 7 and day 14. Method of measurement: ELISA kit.;TAC antioxidant factor. Timepoint: At baseline, day 7 and day 14. Method of measurement: ELISA kit.;MDA antioxidant factor. Timepoint: At baseline, day 7 and day 14. Method of measurement: ELISA kit.;SOFA disease severity measure. Timepoint: At baseline, day 7 and day 14. Method of measurement: SOFA score questionnaire.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSajedeh Jandari

Mashhad University of Medical Sciences

sjandaris@gmail.com+98 51 3800 2418

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026