Clinical trial NCT02550860: Influence of Fish Oil Based Intravenous Fat Emulsions on the Epidermal Barrier Function
Official title: Influence of Fish Oil Based Intravenous Fat Emulsions on the Epidermal Barrier Function
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Intestinal Diseases
Keywords: intravenous fat emulsions
parenteral nutrition
skin barrier function
essential fatty acids
transepidermal water loss
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-09-16
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The epidermal barrier efficacy is determined by the physicochemical properties of the epidermal lipid matrix, among which ω-6 essential fatty acids (EFAs) play a key role. Inversely, the ω-3 EFAs are not found in the epidermis. For patients receiving lipid-containing parenteral nutrition (LCPN), the improvement of the epidermal barrier through the infusion of most appropriate intravenous fat emulsions (IVFE) could have many applications in clinical nutrition, mainly limiting water loss in patients receiving long-term LCPN and help in electrolyte and water balance.

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.


Eligibility criteria: Inclusion Criteria:

* Patient with sever chronic intestinal disease requiring long term parenteral nutrition
* 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:

* Lesser expected parenteral nutrition length than duration for the entire trial
* 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

Primary outcomes:
measure: Measurement of the transepidermal water loss (TEWL).
timeFrame: at Day 0 (at recruitment time)
measure: Measurement of the transepidermal water loss (TEWL).
timeFrame: at Day 90
measure: Measurement of the transepidermal water loss (TEWL).
timeFrame: at Day 180
Secondary outcomes:
measure: Determination of erythrocyte fatty acids ω-6
timeFrame: at Day 0
measure: Determination of erythrocyte fatty acids ω-3
timeFrame: at Day 0
measure: Determination of erythrocyte fatty acids ω-6
timeFrame: at Day 90
measure: Determination of erythrocyte fatty acids ω-3
timeFrame: at Day 90
measure: Determination of erythrocyte fatty acids ω-6
timeFrame: at Day 180
measure: Determination of erythrocyte fatty acids ω-3
timeFrame: at Day 180
measure: Determination of Stratum corneum (SC) ω-3
timeFrame: at Day 0
measure: Determination of Stratum corneum (SC) ω-6
timeFrame: at Day 0
measure: Determination of Stratum corneum (SC) ω-3
timeFrame: at Day 90
measure: Determination of Stratum corneum (SC) ω-6
timeFrame: at Day 90
measure: Determination of Stratum corneum (SC) ω-3
timeFrame: at Day 180
measure: Determination of Stratum corneum (SC) ω-6
timeFrame: at Day 180
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Pierre Bénite
country: France
facility: Centre Hospitalier Lyon Sud
Study officials:
affiliation: Hospices Civils de Lyon
name: Didier Barnoud, MD
role: PRINCIPAL_INVESTIGATOR
References: