Evidence map›Paper›PMID 30501620›Full record

Trial reportNutrition journal2018

Efficacy of a long-term home parenteral nutrition regimen containing fish oil-derived n-3 polyunsaturated fatty acids: a single-centre, randomized, double blind study.

Helene Bohnert, Max Maurer, Philip C Calder, Johann Pratschke, Paul Thul, Verena Müller

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nutrition journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00530738 (Efficacy, Safety and Quality of Life of a Long-term Home Parenteral Nutrition Regimen With Either LIPIDEM® or LIPOFUNDIN® MCT a Mono-center, Randomized, Double Blind Study), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.8field-weighted citation impact, top 29% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00530738 phase4completednot on this map

Efficacy, Safety and Quality of Life of a Long-term Home Parenteral Nutrition Regimen With Either LIPIDEM® or LIPOFUNDIN® MCT a Mono-center, Randomized, Double Blind Study

TypeinterventionalSponsorB. Braun Melsungen AGRan2007 to 2014Enrolled42ConditionsMalnutritionArmsLipoplus, Lipofundin MCT
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 12 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 2 countries.

Helene BohnertCharité-Universitätsmedizin Berlin, Department of Surgery, Campus Charité Mitte | Campus Virchow-Klinikum, Chariteplatz 1, 10117, Berlin, Germany.
Max MaurerCharité-Universitätsmedizin Berlin, Department of Surgery, Campus Charité Mitte | Campus Virchow-Klinikum, Chariteplatz 1, 10117, Berlin, Germany.
Philip C CalderHuman Development and Health, Faculty of Medicine, University of Southampton, Southampton, UK.
Johann PratschkeCharité-Universitätsmedizin Berlin, Department of Surgery, Campus Charité Mitte | Campus Virchow-Klinikum, Chariteplatz 1, 10117, Berlin, Germany.
Paul ThulCharité-Universitätsmedizin Berlin, Department of Surgery, Campus Charité Mitte | Campus Virchow-Klinikum, Chariteplatz 1, 10117, Berlin, Germany.
Verena MüllerCharité-Universitätsmedizin Berlin, Department of Surgery, Campus Charité Mitte | Campus Virchow-Klinikum, Chariteplatz 1, 10117, Berlin, Germany. verena.mueller@charite.de.ORCID 0000-0002-0967-6723
Charité - Universitätsmedizin Berlin · DEUniversity Hospital Southampton NHS Foundation Trust · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundData on the use of lipid emulsions containing fish-oil (FO) derived n-3 polyunsaturated fatty acids (n-3 PUFAs) in addition to medium- and long-chain triglycerides (MCT/LCT) for long-term home parenteral nutrition (HPN) are limited. This study aimed to compare HPN regimens containing either MCT/LCT/FO-derived n-3 PUFAs (test group) or MCT/LCT (control group) with respect to efficacy and safety during 8 weeks of HPN using a non-inferiority trial design with change of body mass index (BMI) as primary endpoint.

methodsThis prospective, randomized, double-blind study was conducted at the Charité, Berlin, Germany, from 02/2008 until 01/2014. Adult patients (n = 42; aged 18 to 80 years) requiring HPN for at least 8 weeks were randomly assigned to the test or control group. Assessments included weight, height, physical examination (cardiovascular system, abdomen, respiratory tract, liver, spleen, kidney, urine tract, skin, mucous membrane, neurology, psyche, musculoskeletal system, lymph nodes), bio impedance analysis, calorimetry, blood samplings (haematology, biochemistry, fatty acid analysis) and quality of life questionnaire.

resultsBMI increased in both groups with 8 weeks of HPN (ΔBMI

conclusionsThe HPN regimen prepared with MCT/LCT/FO-derived n-3 PUFAs was at least as efficient in maintaining or even improving nutritional status during HPN as the control MCT/LCT regimen. Administration of FO-derived n-3 PUFAs for 8 weeks altered the fatty acid pattern of serum, platelet and red blood cell phospholipids. Both regimens were safe and well tolerated.

trial registrationwww.clinicaltrials.gov , registration number: NCT00530738.

Indexed as

Nutritional StatusAdolescentAdultAgedAged, 80 and overBody Mass IndexDouble-Blind MethodFat Emulsions, IntravenousFatty Acids, Omega-3FemaleFish OilsGermanyHumansMaleMiddle AgedParenteral Nutrition, HomeFat Emulsions, IntravenousFatty Acids, Omega-3Fish OilsFish oilHome parenteral nutritionLipid emulsionN-3 polyunsaturated fatty acids

Identifiers

PMID30501620
PMCPMC6271579
OpenAlexW2902454812

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.