Status:
COMPLETED
Effect of Parenteral Nutrition With n-3 PUFAs on Patients With Intestinal Failure
Lead Sponsor:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Conditions:
Intestinal Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03869957
Start Date
December 1 2019
End Date
June 30 2022
Last Update
September 25 2025
Active Locations (1)
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1
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, Tlalpan, Mexico, 14080