Trials / Completed
CompletedNCT03282955
The HOME Study (HPN With OMEGA-3)
A Randomized, Controlled, Double-blind, Multicenter Clinical Trial on Home Parenteral Nutrition Using an Omega-3 Fatty Acid Enriched MCT/LCT Lipid Emulsion
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 74 (actual)
- Sponsor
- B. Braun Melsungen AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of the trial is to investigate safety and tolerability of an Omega-3-FA-enriched lipid emulsion in adult patients with chronic intestinal failure in need of long-term HPN. It is aimed to show non-inferiority of the lipid emulsion Lipidem (investigational test product) in comparison to the lipid emulsion Lipofundin MCT (investigational reference product) with regard to liver function.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lipidem | Lipoplus i.v. lipid emulsion for parenteral nutrition |
| DRUG | Lipofundin MCT 20% | Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition |
Timeline
- Start date
- 2018-01-08
- Primary completion
- 2022-07-19
- Completion
- 2022-07-19
- First posted
- 2017-09-14
- Last updated
- 2025-07-04
- Results posted
- 2025-07-04
Locations
9 sites across 5 countries: France, Italy, Netherlands, Poland, United Kingdom
Source: ClinicalTrials.gov record NCT03282955. Inclusion in this directory is not an endorsement.