CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 69 enrolled
Drug / intervention
Atémpero +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06726486
NCT06726486Phase 4Completed

Use of a Hypercaloric and Hyperprotein Supplement Enriched with Immunonutrients in Multi-pathological Malnourished Patients to Improve the Incidence and Prevalence of Pressure Sores: a Randomized Controlled Trial

University of Cadiz·interventional·Posted Dec 10, 2024·Updated Dec 10, 2024

In Brief

A Phase 4 clinical trial evaluating Atémpero and Control (Standard treatment) for Multimorbidity and 3 related conditions. Completed, enrolled 69 participants across 1 site.

Detailed Summary

The goal of this study is to evaluate the efficacy of a hypercaloric, hyperproteic enteral formula enriched with immunonutrients in preventing and treating pressure injuries in hospitalized malnourished patients. Participants will take enteral formula (a complete hyperproteic and hypercaloric oral nutritional supplement with a fibre mixture enriched in omega 3, L-arginine and nucleotides, providing vitamin C and Zinc) or a hyperproteic and hypercaloric oral nutritional supplement with fibre mixture every day for 30 days.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedDec 10, 2024
Enrollment StartJan 1, 2022
Primary CompletionApr 30, 2023
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 1.6 years ago

Interventions

Atémperodietary

A complete hyperproteic and hypercaloric diet with a mixture of fibres enriched in omega 3, L-arginine and nucleotides (which provides vitamin C and Zinc) was administered.

Control (Standard treatment)dietary

A complete high-protein and high-calorie diet with mixed fibre was administered.