Influence of Fish Oil Based Intravenous Fat Emulsions on the Epidermal Barrier Function
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Measurement of the transepidermal water loss (TEWL).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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
排除标准
- •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
研究组 & 干预措施
soybean oil (SO)-based IVFE (Medialipide)
干预措施: soybean oil (SO)-based IVFE (Medialipide) (Drug)
fish oil (FO)-containing IVFE (Lipidem)
fish oil (FO)-containing IVFE (Lipidem)
干预措施: fish oil (FO)-containing IVFE (Lipidem) (Drug)
结局指标
主要结局
Measurement of the transepidermal water loss (TEWL).
时间窗: at Day 180
Measurement will be performed in a horizontal plane on the dominant volar forearm, which is the reference site for TEWL measurement because of its low content of sebaceous glands and pilosity. The TEWL will be measured using the latest generation of closed chamber system, combined to a vapor water condenser (Aquaflux 200®), which offers the advantage of a reduced TEWL value sensitivity to ambient humidity and temperature during measurement.
次要结局
- Determination of erythrocyte fatty acids ω-3(at Day 180)
- Determination of Stratum corneum (SC) ω-6(at Day 180)
- Determination of erythrocyte fatty acids ω-6(at Day 180)
- Determination of Stratum corneum (SC) ω-3(at Day 180)