Evidence map›Paper›PMID 26465792›Full record

Trial reportJournal of pediatric gastroenterology and nutrition2016

Choline Supplementation With a Structured Lipid in Children With Cystic Fibrosis: A Randomized Placebo-Controlled Trial.

Joan I Schall, Maria R Mascarenhas, Asim Maqbool, Kelly A Dougherty, Okan Elci, Dah-Jyuu Wang, Talissa A Altes, Kevin A Hommel, Walter Shaw, Jeff Moore and 1 more

Open access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of pediatric gastroenterology and nutrition, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
2.1field-weighted citation impact, top 14% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 23 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Review
  7. Bone accrual and structural changes over one year in youth with cystic fibrosis.Journal of clinical & translational endocrinology · 2022
    Article
  8. Review
  9. Review
  10. Article
  11. Article
  12. Article
  13. Choline.Advances in nutrition (Bethesda, Md.) · 2018
    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

11 authors at 5 institutions in 1 country.

Joan I Schall*Division of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Philadelphia, Philadelphia, PA ‡The Richard Stockton College of New Jersey NJ §Biostatistics and Data Management Core ||Department of Radiology, Children's Hospital of Philadelphia, Philadelphia, PA ¶Department of Radiology and Medical Imaging, University of Virginia, Charlottesville, VA #Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH **Avanti Polar Lipids, Inc, Alabaster, AL.
Maria R Mascarenhas
Asim Maqbool
Kelly A Dougherty
Okan Elci
Dah-Jyuu Wang
Talissa A Altes
Kevin A Hommel
Walter Shaw
Jeff Moore
Virginia A Stallings
Children's Hospital of Philadelphia · USAvanti Polar Lipids (United States) · USCincinnati Children's Hospital Medical Center · USStockton University · USUniversity of Virginia · US

Funding

INSTITUTIONAL CLINICAL AND TRANSLATIONAL SCIENCE AWARDUL1RR024134 · NCRR · UNIVERSITY OF PENNSYLVANIA · PI FITZGERALD, GARRET A · 2006 to 2011
$70.4M
Institutional Clinical and Translational Science AwardUL1TR000003 · NCATS · UNIVERSITY OF PENNSYLVANIA · PI FITZGERALD, GARRET A · 2012 to 2015
$38.9M
Organized Lipid Matrix: Fatty Acids and Choline in Cystic FibrosisR44DK060302 · NIDDK · AVANTI POLAR LIPIDS, INC. · PI SHAW, WALTER A · 2006 to 2008
$6.2M
NCATS NIH HHS UL1 TR000003NCATS NIH HHS UL1TR000003NCRR NIH HHS UL1 RR024134NCRR NIH HHS UL1RR024134NIDDK NIH HHS R44 DK060302NIDDK NIH HHS R44DK060302
6 · The paper itself

Abstract

backgroundCholine depletion is seen in cystic fibrosis (CF) and pancreatic insufficiency in spite of enzyme treatment and may result in liver, fatty acid, and muscle abnormalities. This study evaluated the efficacy and safety of an easily absorbed choline-rich structured lipid (LYM-X-SORB™ [LXS]) to improve choline status.

methodsChildren with CF and pancreatic insufficiency were randomized to LXS or placebo in a 12-month double blind trial. Dietary choline intake, plasma cholines, plasma and fecal phospholipids, coefficient of fat absorption, pulmonary function, growth status, body composition, and safety measures were assessed. Magnetic resonance spectroscopy for calf muscle choline and liver fat were assessed in a subgroup and compared with a healthy comparison group matched for age, sex, and body size.

resultsA total of 110 subjects were enrolled (age 10.4 ± 3.0 years). Baseline dietary choline, 88% recommended, increased 3-fold in the LXS group. Plasma choline, betaine, and dimethylglycine increased in the LXS but not placebo (P = 0.007). Plasma lysophosphatidylcholine and phosphatidylcholine increased, and fecal phosphatidylcholine/phosphatidylethanolamine ratio decreased (P ≤ 0.05) in LXS only, accompanied by a 6% coefficient of fat absorption increase (P = 0.001). Children with CF had higher liver fat than healthy children and depleted calf muscle choline at baseline. Muscle choline concentration increased in LXS and was associated with improvement in plasma choline status. No relevant changes in safety measures were evident.

conclusionsLXS had improved choline intake, plasma choline status, and muscle choline stores compared with placebo group. The choline-rich supplement was safe, accepted by participants, and improved choline status in children with CF.

Indexed as

Adolescent Nutritional Physiological PhenomenaChild Nutritional Physiological PhenomenaDietary FatsDietary SupplementsNutritional StatusAdolescentChildChild, PreschoolCholineCholine DeficiencyCystic FibrosisDouble-Blind MethodFemaleHumansIntestinal AbsorptionLegCholineDietary FatsLysophosphatidylcholines

Identifiers

PMID26465792
PMCPMC4805439
OpenAlexW1818336391

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.