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Effect of Parenteral Nutrition With n-3 PUFAs on Patients With Intestinal Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03869957
Recruitment Status : Recruiting
First Posted : March 11, 2019
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Aurora Elizabeth Serralde Zúñiga, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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).

Condition or disease Intervention/treatment Phase
Intestinal Failure Dietary Supplement: Intervention group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind, controlled clinical trial
Masking: Double (Participant, Investigator)
Masking Description: A team researcher will use Stata 12, to perform randomization with a 1:1 allocation using random block sizes of 4. Once the treatment group is determined, the PN will be prescribed accordingly and the preparation will be carried out in the pharmacy and it will have the same appearance in both arms. Patients and researchers who will evaluate the outcomes and perform the statistical analysis will be blinded to the assigned group.
Primary Purpose: Treatment
Official Title: Effect of Parenteral Nutrition With n-3 PUFAs on Patients With Intestinal Failure
Actual Study Start Date : February 21, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group
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
0.1-0.2 g n-3 PUFA/kg body weight/day for 7 days
Other Name: n-3 PUFAs

No Intervention: Control group
Will be administering ~1.0 g/kg/d the lipid emulsion Clinoleic® (80% olive oil/20 soybean oil) without n-3 PUFAs.



Primary Outcome Measures :
  1. Change of malondialdehyde (MDA) in serum from baseline to day 7 [ Time Frame: Change from baseline (day 0) at day 7 ]
    Measurement of malondialdehyde (MDA) that is a marker for oxidative stress, determined in serum in ng/dl.


Secondary Outcome Measures :
  1. Change of glutathione (GSH) in plasma from baseline to day 7 [ Time Frame: Change from baseline (day 0) at day 7 ]
    Measurement of glutathione (GSH) that is a marker for oxidative stress, determined in plasma in micromol/l.

  2. Change of oxidized glutathione (GSSG) in plasma from baseline to day 7 [ Time Frame: Change from baseline (day 0) at day 7 ]
    Measurement of oxidized glutathione (GSSG) that is a marker for oxidative stress, determined in plasma in micromol/l.

  3. Change of GSH/GSSG ratio from baseline to day 7 [ Time Frame: Change from baseline (day 0) at day 7 ]
    GSH and GSSG will be combined to report GSH/GSSG ratio in micromol/l

  4. Change of carbonylated protein in serum from baseline to day 7. [ Time Frame: Change from day 0 at day 7. ]
    Measurement of carbonylated protein that is a marker for oxidative stress, determined in serum in nmol/mg

  5. Change of lipopolysaccharide (LPS) in serum from baseline to day 7. [ Time Frame: Change from baseline (day 0) at day 7 ]
    Measurement of lipopolysaccharide (LPS) that is a marker for metabolic endotoxemia, determined in serum in ng/dl.

  6. Change of C-reactive protein (CRP) in serum from baseline to day 7. [ Time Frame: Change from baseline (day 0) at day 7 ]
    Measurement of C-reactive protein (CRP) that is a marker for inflammation, determined in serum in pg/ml.

  7. Change of glucose in serum from baseline to day 7 [ Time Frame: Change from baseline (day 0) at day 7 ]
    Concentration of glucose in serum according medical records, in mg/dl

  8. Change of nitrogen ureic in serum from baseline to day 7 [ Time Frame: Change from baseline (day 0) at day 7 ]
    Concentration of nitrogen ureic in serum according medical records, in mg/dl

  9. Change of urea in serum from baseline to day 7 [ Time Frame: Change from baseline (day 0) at day 7 ]
    Concentration of urea in serum according medical records, in mg/dl

  10. Change of creatinin in serum from baseline to day 7 [ Time Frame: Change from baseline (day 0) at day 7 ]
    Concentration of creatinin in serum according medical records, in mg/dl

  11. Change of sodium in serum from baseline to day 7 [ Time Frame: Change from baseline (day 0) at day 7 ]
    Concentration of sodium in serum according medical records, in mmol/l

  12. Change of potassium in serum from baseline to day 7 [ Time Frame: Change from baseline (day 0) at day 7 ]
    Concentration of potassium in serum according medical records, in mmol/l

  13. Change of phosphorus in serum from baseline to day 7 [ Time Frame: Change from baseline (day 0) at day 7 ]
    Concentration of phosphorus in serum according medical records, in mg/dl

  14. Change of magnesium in serum from baseline to day 7 [ Time Frame: Change from baseline (day 0) at day 7 ]
    Concentration of magnesium in serum according medical records, in mg/dl

  15. Change of total bilirubin in serum from baseline to day 7 [ Time Frame: Change from baseline (day 0) at day 7 ]
    Concentration of total bilirubin in serum according medical records, in mg/dl

  16. Change of direct bilirubin in serum from baseline to day 7 [ Time Frame: Change from baseline (day 0) at day 7 ]
    Concentration of direct bilirubin in serum according medical records, in mg/dl

  17. Change of indirect bilirubin in serum from baseline to day 7 [ Time Frame: Change from baseline (day 0) at day 7 ]
    Concentration of indirect bilirubin in serum according medical records, in mg/dl

  18. Change of alanine aminotransferase in serum from baseline to day 7 [ Time Frame: Change from baseline (day 0) at day 7 ]
    Concentration of alanine aminotransferase in serum according medical records, in U/l

  19. Change of aspartate aminotransferase in serum from baseline to day 7 [ Time Frame: Change from baseline (day 0) at day 7 ]
    Concentration of aspartate aminotransferase in serum according medical records, in U/l

  20. Change of alkaline phosphatase in serum from baseline to day 7 [ Time Frame: Change from baseline (day 0) at day 7 ]
    Concentration of alkaline phosphatase in serum according medical records, in U/l

  21. Frequency of patients with nutritional risk at baseline [ Time Frame: At baseline (day 0) ]
    Determine the frequency of patients with nutritional risk according the Nutritional Risk Assesment-2002 (NRS-2002) tool, in percentage.

  22. Determine the type of intestinal failure at baseline. [ Time Frame: At baseline (day 0) ]
    Identify the classification of patients with intestinal failure according the ESPEN guidelines on chronic intestinal failure in adults, in percentage.

  23. Frequency of primary diagnosis at baseline. [ Time Frame: At baseline (day 0) ]
    Determine the frequency of primary diagnosis according medical records, in percentage.

  24. Assessment of resting energy expenditure at baseline [ Time Frame: Baseline (day 0) ]
    Measurement of resting energy expenditure at baseline with a calorimeter, in kcal/day

  25. Assessment of nutritional prescription at baseline and at day 7 [ Time Frame: At baseline (day 0) and at day 7 ]
    Determine the nutritional prescription at baseline, in kcal/day

  26. Frequency of the type and characteristics of nutritional support administered [ Time Frame: At baseline (day 0) and at day 7 ]
    Determine type and characteristics of nutritional support administered, according medical records, in percentage

  27. Assessment of height at baseline [ Time Frame: Baseline (day 0) ]
    Measurement of weight in centimeters

  28. Assessment of weight at baseline and at the end of the follow-up [ Time Frame: At baseline (day 0) and at the end of the follow-up (~ at day 30) ]
    Measurement of weight in kilograms

  29. Assessment of body mass index at baseline and at the end of the follow-up [ Time Frame: At baseline (day 0) and at the end of the follow-up (~ at day 30) ]
    Weight and height will be combined to report BMI in kg/m^2

  30. Assessment of percentage of lean mass at baseline and at the end of the follow-up [ Time Frame: At baseline (day 0) and at the end of the follow-up (~ at day 30) ]
    Measurement of percentage of lean mass at baseline with a electric bioimpedance (InBody S10 ®).

  31. Assessment of percentage of fat mass at baseline and at the end of the follow-up [ Time Frame: At baseline (day 0) and at the end of the follow-up (~ at day 30) ]
    Measurement of percentage of fat mass at baseline with a electric bioimpedance (InBody S10 ®).

  32. Assessment of muscle function at baseline and at the end of the follow-up [ Time Frame: At baseline (day 0) and at the end of the follow-up (~ at day 30) ]
    Measurement of muscle function with a handgrip at baseline, in kilograms

  33. Length of stay at hospitalization area [ Time Frame: From the date of admission to the date of discharge from the hospitalization area (~ at day 30) ]
    Determine the length of stay from the date of admission to the date of discharge from the hospitalization area, in days

  34. Rate of mortality [ Time Frame: At the end of the follow-up (~ at day 30) ]
    Evaluation of frequency of mortality, in percentage

  35. Frequency of intestinal failure-associated liver disease (IFALD) [ Time Frame: From baseline (day 0) to the end of the follow-up (~ at day 30) ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03869957


Contacts
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Contact: Aurora E Serralde Zúñiga, MD, PhD 525554870900 ext 2193 aurozabeth@yahoo.com.mx

Locations
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Mexico
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán Recruiting
Ciudad de México, Tlalpan, Mexico, 14080
Contact: Aurora E Serralde Zúñiga, MD, PhD    54870900 ext 2193    aurozabeth@yahoo.com.mx   
Sub-Investigator: Mathy V Alonso Ocaña, MS         
Sub-Investigator: Ana L Reyes Ramírez, MD         
Sub-Investigator: Martha Guevara Cruz, MD, PhD         
Sub-Investigator: Luis E González Salazar, MS         
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Investigators
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Principal Investigator: Aurora E Serralde-Zúñiga, MD, PhD Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Publications of Results:

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Responsible Party: Aurora Elizabeth Serralde Zúñiga, Principal Investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT03869957    
Other Study ID Numbers: 2846
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aurora Elizabeth Serralde Zúñiga, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
omega 3 polyunsaturated fatty acids
intestinal failure
oxidative stress