Clinical trial NCT03869957: Effect of Parenteral Nutrition With n-3 PUFAs on Patients With Intestinal Failure
Official title: Effect of Parenteral Nutrition With n-3 PUFAs on Patients With Intestinal Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intestinal Failure
Keywords: omega 3 polyunsaturated fatty acids
intestinal failure
oxidative stress
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, controlled clinical trial
Primary purpose: TREATMENT

Brief summary: Randomized, double-blind, controlled clinical trial to evaluate the effect of parenteral nutrition (PN) supplemented with lipid emulsions containing 0.1-0.2 g omega 3 polyunsaturated fatty acids (n-3 PUFA)/kg body weight/day for 7 days on malondialdehyde (MDA) levels, a marker of lipoperoxidation of reactive species, compared with a control group (without n-3 PUFA) in patients with intestinal failure (IF).

Detailed description: IF is the loss of intestinal function that affects the decrease in the absorption of macronutrients, water, and electrolytes, so it requires intravenous supplementation such as PN and/or intravenous fluids to maintain health and/or growth. IF type II is associated with complex infectious and metabolic complications and patients require PN for weeks or months. Long-term PN use, however, includes the risk of complications, among which a serious one is the intestinal failure-associated liver disease (1). It has been proposed that metabolic endotoxemia (2-3), inflammation (4) and oxidative stress (5) are involved in the development of this intestinal failure-associated liver disease.

Although some studies have reported beneficial effects of n-3 PUFA to prevent and reverse the liver disease associated with IF (6-7), due to its antioxidant (8-10) and anti-inflammatory activity (11-12) and in the modulation of the intestinal microbiota (13), the literature on the use of n-3 PUFA in non-critical patients with IF and PN is limited and the results have not been conclusive.

Therefore, a randomized, double-blind, controlled clinical trial to evaluate the effect of PN supplemented with lipid emulsions containing n-3 PUFA/kg body weight/day for 7 days on oxidative stress (concentrations of MDA), compared with a control group (without n-3 PUFA) will be performed.

Eligibility criteria: Inclusion Criteria:

* Patients admitted in the non-critical areas of the Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ) with a nutritional risk between January 2019 and July 2020 will be considered eligible.
* Patients with recent diagnosis of IF type II (an evolution \>28 days) originate from various gastrointestinal or systemic diseases (short bowel, intestinal fistula, intestinal dysmotility, mechanical obstruction, and extensive small bowel mucosal disease).

Exclusion Criteria:

* Patients with contraindications for PN
* Patients with known allergies to the components of the PN formula
* Severe liver or renal insufficiency
* Uncontrolled diabetes mellitus
* Certain acute and life-threatening conditions
* Immunological diseases (such as autoimmune diseases, human immunodeficiency virus infection, cancer, etc.)
* Those that take immunosuppressant medications
* Severe hemorrhagic disorders
* Pregnant or lactating

Primary outcomes:
measure: Change of malondialdehyde (MDA) in serum from baseline to day 7
timeFrame: Change from baseline (day 0) at day 7
Secondary outcomes:
measure: Change of glutathione (GSH) in plasma from baseline to day 7
timeFrame: Change from baseline (day 0) at day 7
measure: Change of oxidized glutathione (GSSG) in plasma from baseline to day 7
timeFrame: Change from baseline (day 0) at day 7
measure: Change of GSH/GSSG ratio from baseline to day 7
timeFrame: Change from baseline (day 0) at day 7
measure: Change of carbonylated protein in serum from baseline to day 7.
timeFrame: Change from day 0 at day 7.
measure: Change of lipopolysaccharide (LPS) in serum from baseline to day 7.
timeFrame: Change from baseline (day 0) at day 7
measure: Change of C-reactive protein (CRP) in serum from baseline to day 7.
timeFrame: Change from baseline (day 0) at day 7
measure: Change of glucose in serum from baseline to day 7
timeFrame: Change from baseline (day 0) at day 7
measure: Change of nitrogen ureic in serum from baseline to day 7
timeFrame: Change from baseline (day 0) at day 7
measure: Change of urea in serum from baseline to day 7
timeFrame: Change from baseline (day 0) at day 7
measure: Change of creatinin in serum from baseline to day 7
timeFrame: Change from baseline (day 0) at day 7
measure: Change of sodium in serum from baseline to day 7
timeFrame: Change from baseline (day 0) at day 7
measure: Change of potassium in serum from baseline to day 7
timeFrame: Change from baseline (day 0) at day 7
measure: Change of phosphorus in serum from baseline to day 7
timeFrame: Change from baseline (day 0) at day 7
measure: Change of magnesium in serum from baseline to day 7
timeFrame: Change from baseline (day 0) at day 7
measure: Change of total bilirubin in serum from baseline to day 7
timeFrame: Change from baseline (day 0) at day 7
measure: Change of direct bilirubin in serum from baseline to day 7
timeFrame: Change from baseline (day 0) at day 7
measure: Change of indirect bilirubin in serum from baseline to day 7
timeFrame: Change from baseline (day 0) at day 7
measure: Change of alanine aminotransferase in serum from baseline to day 7
timeFrame: Change from baseline (day 0) at day 7
measure: Change of aspartate aminotransferase in serum from baseline to day 7
timeFrame: Change from baseline (day 0) at day 7
measure: Change of alkaline phosphatase in serum from baseline to day 7
timeFrame: Change from baseline (day 0) at day 7
measure: Frequency of patients with nutritional risk at baseline
timeFrame: At baseline (day 0)
measure: Determine the type of intestinal failure at baseline.
timeFrame: At baseline (day 0)
measure: Frequency of primary diagnosis at baseline.
timeFrame: At baseline (day 0)
measure: Assessment of resting energy expenditure at baseline
timeFrame: Baseline (day 0)
measure: Assessment of nutritional prescription at baseline and at day 7
timeFrame: At baseline (day 0) and at day 7
measure: Frequency of the type and characteristics of nutritional support administered
timeFrame: At baseline (day 0) and at day 7
measure: Assessment of height at baseline
timeFrame: Baseline (day 0)
measure: Assessment of weight at baseline and at the end of the follow-up
timeFrame: At baseline (day 0) and at the end of the follow-up (~ at day 30)
measure: Assessment of body mass index at baseline and at the end of the follow-up
timeFrame: At baseline (day 0) and at the end of the follow-up (~ at day 30)
measure: Assessment of percentage of lean mass at baseline and at the end of the follow-up
timeFrame: At baseline (day 0) and at the end of the follow-up (~ at day 30)
measure: Assessment of percentage of fat mass at baseline and at the end of the follow-up
timeFrame: At baseline (day 0) and at the end of the follow-up (~ at day 30)
measure: Assessment of muscle function at baseline and at the end of the follow-up
timeFrame: At baseline (day 0) and at the end of the follow-up (~ at day 30)
measure: Length of stay at hospitalization area
timeFrame: From the date of admission to the date of discharge from the hospitalization area (~ at day 30)
measure: Rate of mortality
timeFrame: At the end of the follow-up (~ at day 30)
measure: Frequency of intestinal failure-associated liver disease (IFALD)
timeFrame: From baseline (day 0) to the end of the follow-up (~ at day 30)
Other outcomes:
Locations:
city: Ciudad de México
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
state: Tlalpan
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Aurora E Serralde-Zúñiga, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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