Evidence map›Paper›PMID 17216337›Full record

Trial reportDigestive diseases and sciences2007

Bioavailability of a novel, water-soluble vitamin E formulation in malabsorbing patients.

Konstantinos Papas, John Kalbfleisch, Ricky Mohon

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Digestive diseases and sciences, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 6 pooled it
2.7field-weighted citation impact, top 10% 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

19 citing papers in PubMed, 6 syntheses or guidelines pooled it, 49 citations in OpenAlex.

  1. Pooled it
  2. Vitamin E supplementation in people with cystic fibrosis.The Cochrane database of systematic reviews · 2020
    Pooled it
  3. Oral calorie supplements for cystic fibrosis.The Cochrane database of systematic reviews · 2017
    Pooled it
  4. Vitamin E supplementation in people with cystic fibrosis.The Cochrane database of systematic reviews · 2017
    Pooled it
  5. Oral protein calorie supplementation for children with chronic disease.The Cochrane database of systematic reviews · 2015
    Pooled it
  6. Guideline
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Antioxidant supplementation for lung disease in cystic fibrosis.The Cochrane database of systematic reviews · 2019
    Review
  17. Article
  18. Article
  19. Review
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

3 authors at 2 institutions in 2 countries.

Konstantinos PapasYasoo Health Inc, Johnson City, TN 37604, USA. kpapas@yasoo.com
John Kalbfleisch
Ricky Mohon
East Tennessee State University · USYahoo (Spain) · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In cystic fibrosis (CF), pancreatic insufficiency and a diminished bile acid pool cause malabsorption of important nutrients and dietary components leading to deficiency, poor nutritional status, and oxidative stress. Of particular significance is the malabsorption of fat-soluble nutrients and antioxidants, which are important for normal immune and neurologic function. Patients with CF often are deficient in these compounds despite supplementation with the current standard of care therapy. The objective was to compare the pharmacokinetic profile of this water-soluble vitamin E formulation (Aqua-E) with an oil-based softgel formulation in a malabsorbing patient population. Patients with CF who had documented malabsorption were recruited for participation in this pharmacokinetic study. Patients who met inclusion and exclusion criteria discontinued vitamin E supplementation, except for that in a multivitamin, for 7 to 21 days before the day of dosing. Patients were randomized to a single dose of 20 ml of Aqua-E or three oil-based softgels, which contained equivalent amounts of tocopherols. Blood was drawn from patients at time 0, 2, 4, 8, 24, 48, and 168 hr and analyzed for tocopherols. Eight patients were enrolled in the study and randomized to Aqua-E or softgels. The primary outcome, the absorption of gamma-tocopherol in Aqua-E (AUC=115 micro g/ml(*)hr), was significantly greater than that of oil-based softgels (AUC=25.3 micro g/ml(*)hr; P=0.013). Total-tocopherols (alpha+gamma+delta) in Aqua-E (AUC=294 micro g/ml(*)hr) showed a strong trend toward increased absorption compared with that of oil-based softgels (AUC=117 micro g/ml(*)hr; P=0.09). In conclusion, this novel, water-soluble formulation showed a marked and statistically significant increase in absorption of gamma-tocopherol in malabsorbing patients with CF compared with an oil-based formulation.

Indexed as

AdolescentAdultalpha-TocopherolAntioxidantsArea Under CurveBiological AvailabilityChemistry, PharmaceuticalChildCystic FibrosisDosage Formsgamma-TocopherolHumansIntestinal AbsorptionLipidsMalabsorption SyndromesPolyethylene Glycolsalpha-TocopherolAntioxidantsdelta-tocopherolDosage Formsgamma-TocopherolLipidsPolyethylene GlycolsSolventsTocopherolstocophersolanVitamin EWater

Identifiers

PMID17216337
OpenAlexW2163629663

What OpenQuestion holds

Textmetadata
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.