Influence of Fish Oil Based Intravenous Fat Emulsions on the Epidermal Barrier Function (Tewlip)

Civil Hospices of Lyon

Status and phase

Terminated

Phase 3

Conditions

Intestinal Diseases

Treatments

Drug: soybean oil (SO)-based IVFE (Medialipide)

Drug: fish oil (FO)-containing IVFE (Lipidem)

Study type

Interventional

Funder types

Other

Identifiers

NCT02550860

2012-786

Details and patient eligibility

About

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.

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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