Evidence map›Paper›PMID 26704923›Full record

Trial reportObesity surgery2016

Oral High-Dose Vitamin D Dissolved in Oil Raised Serum 25-Hydroxy-Vitamin D to Physiological Levels in Obese Patients After Sleeve Gastrectomy-A Double-Blind, Randomized, and Placebo-Controlled Trial.

Eva Wolf, Markus Utech, Peter Stehle, Martin Büsing, Hans-Peter Helfrich, Birgit Stoffel-Wagner, Sarah Egert, Birgit Alteheld, Raute Riege, Annette Knapp and 1 more

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Obesity surgery, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 5 pooled it
1.6field-weighted citation impact, top 18% 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

9 citing papers in PubMed, 5 syntheses or guidelines pooled it, 29 citations in OpenAlex.

  1. Pooled it
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  5. Pooled it
  6. Vitamin DObesity surgery · 2017
    Trial
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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 3 institutions in 1 country.

Eva WolfDepartment of General and Visceral Surgery, Klinikum Vest, Dorstener Str. 151, 45657, Recklinghausen, Germany.
Markus UtechDepartment of General and Visceral Surgery, Klinikum Vest, Dorstener Str. 151, 45657, Recklinghausen, Germany.
Peter StehleDepartment of Nutrition and Food Sciences, Nutritional Physiology, University of Bonn, Endenicher Allee 11-13, 53115, Bonn, Germany.
Martin BüsingDepartment of General and Visceral Surgery, Klinikum Vest, Dorstener Str. 151, 45657, Recklinghausen, Germany.
Hans-Peter HelfrichInstitute for Numerical Simulation, University of Bonn, Endenicher Allee 60, 53115, Bonn, Germany.
Birgit Stoffel-WagnerDepartment of Clinical Chemistry and Clinical Pharmacology, University Hospital Bonn, Sigmund-Freud-Str. 25, 53127, Bonn, Germany.
Sarah EgertDepartment of Nutrition and Food Sciences, Nutritional Physiology, University of Bonn, Endenicher Allee 11-13, 53115, Bonn, Germany.
Birgit AlteheldDepartment of Nutrition and Food Sciences, Nutritional Physiology, University of Bonn, Endenicher Allee 11-13, 53115, Bonn, Germany.
Raute RiegeDepartment of General and Visceral Surgery, Klinikum Vest, Dorstener Str. 151, 45657, Recklinghausen, Germany.
Annette KnappDepartment of General and Visceral Surgery, Klinikum Vest, Dorstener Str. 151, 45657, Recklinghausen, Germany.
Sabine EllingerDepartment of Nutrition and Food Sciences, Nutritional Physiology, University of Bonn, Endenicher Allee 11-13, 53115, Bonn, Germany. Sabine.Ellinger@hs-niederrhein.de.ORCID 0000-0002-9988-9406
University of Bonn · DEKlinikum Vest · DEUniversity Hospital Bonn · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOsteomalacia and cardiometabolic disorders are favored in morbidly obese patients due to an inadequate vitamin D (VD) status. Former trials supplementing orally VD (20-50 μg/day) in crystalline form after sleeve gastrectomy (SG) could not stabilize serum 25-hydroxycholecalciferol levels at predefined concentrations (≥50 nmol/l). We hypothesized that VD in an oily suspension would increase its bioavailability resulting in normal serum VD levels minimizing markers of cardiometabolic risk.

methodsMorbidly obese patients (n = 94, BMI 51.8 ± 11.5 kg/m(2)) received orally 80 μg/day VD3 dissolved in oil or placebo (pure oil) in a randomized, double-blind, parallel-group study for 12 weeks after SG. 25-hydroxycholecalciferol, parathyroid hormone, albumin, alkaline phosphatase, phosphate, magnesium, calcium, creatinine, C-reactive protein, lipids, glucose, and glycated hemoglobin were determined in serum/plasma before surgery and after 4 and 12 weeks of supplementation. Intake of energy, fat, and VD were monitored using a 3-day food record.

resultsSeventy-nine patients were included in statistical analysis. Preoperatively, 77.2 and 40.5 % presented 25-hydroxycholecalciferol levels <75 and <50 nmol/l, respectively. After 12 weeks of supplementation, significantly more patients in the VD group exhibited levels >50 nmol/l (92 %) and >75 nmol/l (68 %) compared to the placebo group (54 and 22 %, respectively). Parameters of mineral metabolism and cardiometabolic risk were not modulated by intervention.

conclusionSupplementation of 80 μg/day VD3 by oil is an effective and safe measure to prevent VD deficiency and to treat a preexisting undersupply in patients after SG. Cardiometabolic risk factors were, however, not affected; probably, higher VD doses might be necessary. CLINICAL

trial registrationThis trial was registered retrospectively on November 14, 2014, at the German Clinical Trials Register as DRKS00007143.

Indexed as

Dietary SupplementsAdministration, OralAdultDouble-Blind MethodFemaleGastrectomyHumansMaleObesity, MorbidPostoperative PeriodTreatment OutcomeVitamin DVitamin D Deficiency25-hydroxyvitamin DVitamin D25-hydroxycholecalciferolBariatric surgeryObesitySleeve gastrectomySupplementationVitamin D

Identifiers

PMID26704923
OpenAlexW2217223843

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.