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Nutrition supplement for tube feeding assessed in hospitalized (ICU Stay) patients

A prospective, open label, single arm, multicenter, interventional, study to assess the efficacy and tolerability of early enteral nutrition in hospitalized patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/12/047818
Enrollment
40
Registered
2022-12-01
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Health Condition 1: Z209- Contact with and (suspected) exposure to unspecified communicable disease

Interventions

Intervention1: Celevida MaXX Enteral Nutrition Formula: Dose: CELEVIDA MAXX EN is an Enteral and oral nutritional supplement (Dr. Reddy’s Laboratories). This product is designed to deliver 1 to 2 Kca

Sponsors

Dr Reddys Laboratories
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) To study the impact of tube feeding supplement for achieving the target Macro Nutrients levels 2) To study the number of days required to reach the target Macro Nutrients levels

Exclusion criteria

Exclusion criteria: 1) To study the impact of EN supplement on total protein, micronutrient levels such as Zn, Vitamin C, Mg, potassium and Phosphorous. 2) To study the impact of tube feeding supplement events of abdominal pain, distension, vomiting and diarrhea after EN supplement 3) To assess the number and reasons of interruptions during the tube feeding and ease of titration of the formula 4) To assess the impact of tube feeding supplement on hematological parameters from baseline to the end of the study. 5) To evaluate the palatability of the formulation in patients shifted to ward’s, through oral supplementation

Design outcomes

Primary

MeasureTime frame
1) Ease of achieving desired target, no. of days required to achieve the target and no. of days of ICU stay. Timepoint: Baseline Visit, Day 1, Day 2, Day 3, Day 4-8, Day 8-14, End of study assessment.

Secondary

MeasureTime frame
1) Improved vital status 2) No Interruptions to feeding 3) Absence of GIT complications- abdominal distention, vomiting and pain post starting of EN 4) Biochemical profile changes like blood glucose, BUN, LFT, Serum Pre albumin Levels 5) Palatability of the powder in ward patientsTimepoint: Baseline Visit, Day 1, Day 2, Day 3, Day 4-8, Day 8-14, End of study assessment.

Countries

India

Contacts

Public ContactDr Rahul Rathod

Dr Reddys Laboratories

Rahul.Rathod@drreddys.com04049048400

Outcome results

None listed

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