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

NCT02550860 | Terminated Phase 3

• 1 other identifier: 2012-786
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

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.

Conditions

Intestinal Diseases

Keywords

intravenous fat emulsions; parenteral nutrition; skin barrier function; essential fatty acids; transepidermal water loss

Outcome Measures

Primary Outcomes (3)

• Measurement of the transepidermal water loss (TEWL).

  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.

  at Day 0 (at recruitment time)

• Measurement of the transepidermal water loss (TEWL).

  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.

  at Day 90

• Measurement of the transepidermal water loss (TEWL).

  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.

  at Day 180

Secondary Outcomes (12)

• Determination of erythrocyte fatty acids ω-6

  at Day 0

• Determination of erythrocyte fatty acids ω-3

  at Day 0

• Determination of erythrocyte fatty acids ω-6

  at Day 90

• Determination of erythrocyte fatty acids ω-3

  at Day 90

• Determination of erythrocyte fatty acids ω-6

  at Day 180

Study Arms (2)

soybean oil (SO)-based IVFE (Medialipide)

ACTIVE COMPARATOR

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

fish oil (FO)-containing IVFE (Lipidem)

ACTIVE COMPARATOR

fish oil (FO)-containing IVFE (Lipidem)

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

Interventions

soybean oil (SO)-based IVFE (Medialipide) DRUG

The soybean oil (SO)-based IVFE will be allocated for a 3-month period, allowing sufficient timeframe for epidermal complete renewal.

soybean oil (SO)-based IVFE (Medialipide)

fish oil (FO)-containing IVFE (Lipidem) DRUG

The fish oil (FO)-containing IVFE will be allocated for a 3-month period, allowing sufficient timeframe for epidermal complete renewal.

fish oil (FO)-containing IVFE (Lipidem)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

Hospices Civils de Lyon

Lyon, 69002, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

MeSH Terms

Conditions

Intestinal Diseases; Hyperphagia

Interventions

Soybean Oil; Fish Oils

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Didier Barnoud, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2015
• First Posted: September 16, 2015
• Study Start: January 1, 2015
• Primary Completion: September 8, 2017
• Study Completion: September 8, 2017
• Last Updated: February 28, 2018

Record last verified: 2018-02

Locations

FR (2)