An interventional study of Intervention group in Intestinal Failure, sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran. Completed at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-25.
Sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · Not applicable, Interventional, and Treatment
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).
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.
64 studies on the registry are indexed under Intestinal Failure; 17 are open to participants now.
This study's enrollment of 20 is below the median of 38 across 42 interventional studies indexed under Intestinal Failure.
Browse Intestinal Failure studies →Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran is the lead sponsor of 144 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
We will use \~0.8-0.9 g/kg/day of Clinoleic® (80% olive oil/20 soybean oil) + 0.2-0.1 g/kg/day \[Omegaven® \](100% fish oil), to cover the proposed amount of n-3 PUFAs for 7 days. The infusion rate should not exceed 0.5 ml Omegaven® / kg body weight / hour = 0.05 g fish oil / kg body weight / hour. The intervention group will return to PN without n-3 PUFA after 7 days.
Dietary Supplement: Intervention group
Will be administering \~1.0 g/kg/d the lipid emulsion Clinoleic® (80% olive oil/20 soybean oil) without n-3 PUFAs.
0.1-0.2 g n-3 PUFA/kg body weight/day for 7 days
Also known as: n-3 PUFAs
Change of malondialdehyde (MDA) in serum from baseline to day 7
Measurement of malondialdehyde (MDA) that is a marker for oxidative stress, determined in serum in ng/dl.
Time frame: Change from baseline (day 0) at day 7
Change of glutathione (GSH) in plasma from baseline to day 7
Measurement of glutathione (GSH) that is a marker for oxidative stress, determined in plasma in micromol/l.
Time frame: Change from baseline (day 0) at day 7
Change of oxidized glutathione (GSSG) in plasma from baseline to day 7
Measurement of oxidized glutathione (GSSG) that is a marker for oxidative stress, determined in plasma in micromol/l.
Time frame: Change from baseline (day 0) at day 7
Change of GSH/GSSG ratio from baseline to day 7
GSH and GSSG will be combined to report GSH/GSSG ratio in micromol/l
Time frame: Change from baseline (day 0) at day 7
Change of carbonylated protein in serum from baseline to day 7.
Measurement of carbonylated protein that is a marker for oxidative stress, determined in serum in nmol/mg
Time frame: Change from day 0 at day 7.
Change of lipopolysaccharide (LPS) in serum from baseline to day 7.
Measurement of lipopolysaccharide (LPS) that is a marker for metabolic endotoxemia, determined in serum in ng/dl.
Time frame: Change from baseline (day 0) at day 7
Change of C-reactive protein (CRP) in serum from baseline to day 7.
Measurement of C-reactive protein (CRP) that is a marker for inflammation, determined in serum in pg/ml.
Time frame: Change from baseline (day 0) at day 7
Change of glucose in serum from baseline to day 7
Concentration of glucose in serum according medical records, in mg/dl
Time frame: Change from baseline (day 0) at day 7
Change of nitrogen ureic in serum from baseline to day 7
Concentration of nitrogen ureic in serum according medical records, in mg/dl
Time frame: Change from baseline (day 0) at day 7
Change of urea in serum from baseline to day 7
Concentration of urea in serum according medical records, in mg/dl
Time frame: Change from baseline (day 0) at day 7
Change of creatinin in serum from baseline to day 7
Concentration of creatinin in serum according medical records, in mg/dl
Time frame: Change from baseline (day 0) at day 7
Change of sodium in serum from baseline to day 7
Concentration of sodium in serum according medical records, in mmol/l
Time frame: Change from baseline (day 0) at day 7
Change of potassium in serum from baseline to day 7
Concentration of potassium in serum according medical records, in mmol/l
Time frame: Change from baseline (day 0) at day 7
Change of phosphorus in serum from baseline to day 7
Concentration of phosphorus in serum according medical records, in mg/dl
Time frame: Change from baseline (day 0) at day 7
Change of magnesium in serum from baseline to day 7
Concentration of magnesium in serum according medical records, in mg/dl
Time frame: Change from baseline (day 0) at day 7
Change of total bilirubin in serum from baseline to day 7
Concentration of total bilirubin in serum according medical records, in mg/dl
Time frame: Change from baseline (day 0) at day 7
Change of direct bilirubin in serum from baseline to day 7
Concentration of direct bilirubin in serum according medical records, in mg/dl
Time frame: Change from baseline (day 0) at day 7
Change of indirect bilirubin in serum from baseline to day 7
Concentration of indirect bilirubin in serum according medical records, in mg/dl
Time frame: Change from baseline (day 0) at day 7
Change of alanine aminotransferase in serum from baseline to day 7
Concentration of alanine aminotransferase in serum according medical records, in U/l
Time frame: Change from baseline (day 0) at day 7
Change of aspartate aminotransferase in serum from baseline to day 7
Concentration of aspartate aminotransferase in serum according medical records, in U/l
Time frame: Change from baseline (day 0) at day 7
Change of alkaline phosphatase in serum from baseline to day 7
Concentration of alkaline phosphatase in serum according medical records, in U/l
Time frame: Change from baseline (day 0) at day 7
Frequency of patients with nutritional risk at baseline
Determine the frequency of patients with nutritional risk according the Nutritional Risk Assesment-2002 (NRS-2002) tool, in percentage.
Time frame: At baseline (day 0)
Determine the type of intestinal failure at baseline.
Identify the classification of patients with intestinal failure according the ESPEN guidelines on chronic intestinal failure in adults, in percentage.
Time frame: At baseline (day 0)
Frequency of primary diagnosis at baseline.
Determine the frequency of primary diagnosis according medical records, in percentage.
Time frame: At baseline (day 0)
Assessment of resting energy expenditure at baseline
Measurement of resting energy expenditure at baseline with a calorimeter, in kcal/day
Time frame: Baseline (day 0)
Assessment of nutritional prescription at baseline and at day 7
Determine the nutritional prescription at baseline, in kcal/day
Time frame: At baseline (day 0) and at day 7
Frequency of the type and characteristics of nutritional support administered
Determine type and characteristics of nutritional support administered, according medical records, in percentage
Time frame: At baseline (day 0) and at day 7
Assessment of height at baseline
Measurement of weight in centimeters
Time frame: Baseline (day 0)
Assessment of weight at baseline and at the end of the follow-up
Measurement of weight in kilograms
Time frame: At baseline (day 0) and at the end of the follow-up (~ at day 30)
Assessment of body mass index at baseline and at the end of the follow-up
Weight and height will be combined to report BMI in kg/m\^2
Time frame: At baseline (day 0) and at the end of the follow-up (~ at day 30)
Assessment of percentage of lean mass at baseline and at the end of the follow-up
Measurement of percentage of lean mass at baseline with a electric bioimpedance (InBody S10 ®).
Time frame: At baseline (day 0) and at the end of the follow-up (~ at day 30)
Assessment of percentage of fat mass at baseline and at the end of the follow-up
Measurement of percentage of fat mass at baseline with a electric bioimpedance (InBody S10 ®).
Time frame: At baseline (day 0) and at the end of the follow-up (~ at day 30)
Assessment of muscle function at baseline and at the end of the follow-up
Measurement of muscle function with a handgrip at baseline, in kilograms
Time frame: At baseline (day 0) and at the end of the follow-up (~ at day 30)
Length of stay at hospitalization area
Determine the length of stay from the date of admission to the date of discharge from the hospitalization area, in days
Time frame: From the date of admission to the date of discharge from the hospitalization area (~ at day 30)
Rate of mortality
Evaluation of frequency of mortality, in percentage
Time frame: At the end of the follow-up (~ at day 30)
Frequency of intestinal failure-associated liver disease (IFALD)
Determined with the elevation in alkaline phosphatase concentrations within the first 7-14 days with parenteral nutrition, by elevation in transaminase concentrations more than 1.5 times above the upper limit of reference, or by elevation in the total bilirubin or direct bilirubin concentrations \>3, 4, 6 and 12 mg / dl
Time frame: From baseline (day 0) to the end of the follow-up (~ at day 30)
Change in lipidomics in serum from day 0 to day 7
Change in lipidomic profile of the diferent lipid species
Time frame: Change from baseline (day 0) to day 7
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran →