Influence of Fish Oil Based Intravenous Fat Emulsions on the Epidermal Barrier Function
NCT ID: NCT02550860
Last Updated: 2018-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
13 participants
INTERVENTIONAL
2015-01-31
2017-09-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The objective of this interventional clinical trial is to evaluate the epidermal barrier function in patients receiving long-term LCPN comparing two compositions of IVFE: (i) soybean oil (SO)-based IVFE (Medialipide) or (ii) fish oil (FO)-containing IVFE (Lipidem). Epidermal barrier function will be assessed through the transepidermal water loss (TEWL) measurement on the skin surface, a validated marker of the epidermal barrier efficacy. The two IVFE (SO-based or FO-containing) will be compared using a randomized double blind crossover design, using patients as their own control. Each IVFE will be allocated for a 3-month period, allowing sufficient timeframe for epidermal complete renewal. Patient's epidermal and red blood cell EFA profile will be determinate in order to facilitate result interpretation.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Influence of of a Lipid Emulsion on Inflammatory Response and Hepatic Function
NCT00600912
Fish Oil for Patients With Liver Disease Due to Parenteral Nutrition
NCT01565278
Explore Effects of Dietary Fish Oil in Human Skin
NCT03122912
A Study to Evaluate the Effect of Fish Oil Concentrate on Skin Function
NCT07133477
Effects of N-3 Polyunsaturated Fatty Acids On Chylomicron Secretion And Expression Of Genes That Regulate Intestinal Lipid Metabolism In Men With Type 2 Diabetes
NCT01449773
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
soybean oil (SO)-based IVFE (Medialipide)
soybean oil (SO)-based IVFE (Medialipide)
The soybean oil (SO)-based IVFE will be allocated for a 3-month period, allowing sufficient timeframe for epidermal complete renewal.
fish oil (FO)-containing IVFE (Lipidem)
fish oil (FO)-containing IVFE (Lipidem)
fish oil (FO)-containing IVFE (Lipidem)
The fish oil (FO)-containing IVFE will be allocated for a 3-month period, allowing sufficient timeframe for epidermal complete renewal.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
soybean oil (SO)-based IVFE (Medialipide)
The soybean oil (SO)-based IVFE will be allocated for a 3-month period, allowing sufficient timeframe for epidermal complete renewal.
fish oil (FO)-containing IVFE (Lipidem)
The fish oil (FO)-containing IVFE will be allocated for a 3-month period, allowing sufficient timeframe for epidermal complete renewal.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Receiving home lipid containing parenteral nutrition (LCPN), regardless of currently infused intravenous fat emulsion
* With a stable dose of LCPN for at least 1 month at recruitment time
* Administered at least 4 days a week through central venous access, with at least 150 mL of lipid per parenteral nutrition bag with lipid.
* Age \>18
* Being available for 2 medical consultations in a 6 month period
* Who gave its written informed consent to participate to the study and without legal protection
* Social security coverage
Exclusion Criteria
* Dermatological criteria : History of skin disease (atopic dermatitis, psoriasis) or evolving skin disease, broken or inflamed skin on the TEWL measurement site, Use of topical creams on the TEWL measurement site, Skin or systemic allergy (asthma)
* Contraindication to one of the selected intravenous fat emulsion: Severe dyslipidemia; Uncontrolled diabetes; Sepsis; Severe hepatic impairment; Major blood clotting disorders; Egg protein, soybean, peanut or fish hyper sensibility; Serum creatinine clearance \< 30 ml/min
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospices Civils de Lyon
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Didier Barnoud, MD
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospices Civils de Lyon
Lyon, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2012-786
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.