Evidence map›Paper›PMID 26242295›Full record

Trial reportTrials2015

The link between obesity and vitamin D in bariatric patients with omega-loop gastric bypass surgery - a vitamin D supplementation trial to compare the efficacy of postoperative cholecalciferol loading (LOAD): study protocol for a randomized controlled trial.

Maria Luger, Renate Kruschitz, Rodrig Marculescu, Helmuth Haslacher, Friedrich Hoppichler, Enikö Kallay, Christian Kienbacher, Carmen Klammer, Melanie Kral, Felix Langer and 7 more

Registry-linked trialOpen access · goldAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02092376 (The Link Between Obesity And Vitamin D in Bariatric Patients With Omega-loop Bypass Surgery), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
2.4field-weighted citation impact, top 12% 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.

NCT02092376 phase4completednot on this map

The Link Between Obesity And Vitamin D in Bariatric Patients With Omega-loop Bypass Surgery: a Randomized Controlled, Double-blinded Clinical Supplementation Trial

TypeinterventionalSponsorMaria LugerRan2014 to 2016Enrolled50ConditionsBariatric Surgery CandidateArmsCholecalciferol, Placebo
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Impact of bariatric surgery on gut microbiota in obese patients: A systematic review.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2025
    Pooled it
  2. Trial
  3. Vitamin DObesity surgery · 2017
    Trial
  4. Article
  5. Article
  6. Article
  7. Article
  8. 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

17 authors at 1 institution in 1 country.

Maria LugerDivision of Endocrinology and Metabolism, Department of Internal Medicine III, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. maria.luger@meduniwien.ac.at.
Renate KruschitzDivision of Endocrinology and Metabolism, Department of Internal Medicine III, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. renate.kruschitz@meduniwien.ac.at.
Rodrig MarculescuClinical Institute for Medical and Chemical Laboratory Diagnostics, Department of Laboratory Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. rodrig.marculescu@meduniwien.ac.at.
Helmuth HaslacherClinical Institute for Medical and Chemical Laboratory Diagnostics, Department of Laboratory Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. helmuth.haslacher@meduniwien.ac.at.
Friedrich HoppichlerSpecial Institute for Preventive Cardiology and Nutrition - SIPCAN, Guggenbichlerstraße 8/15, 5026, Salzburg, Austria. office@sipcan.at.
Enikö KallayDepartment of Pathophysiology and Allergy Research, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. enikoe.kallay@meduniwien.ac.at.
Christian KienbacherDivision of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. christian.a.kienbacher@meduniwien.ac.at.
Carmen KlammerDivision of Endocrinology and Metabolism, Department of Internal Medicine III, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. n0748048@students.meduniwien.ac.at.
Melanie KralDivision of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. melanie.kral@akhwien.at.
Felix LangerDivision of General Surgery, Department of Surgery, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. felix.langer@meduniwien.ac.at.
Eva LugerInstitute of Social Medicine, Centre for Public Health, Medical University of Vienna, Kinderspitalgasse 15/1, 1090, Vienna, Austria. eva.luger@meduniwien.ac.at.
Gerhard PragerDivision of General Surgery, Department of Surgery, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. gerhard.prager@meduniwien.ac.at.
Michael TraunerDivision of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. michael.trauner@meduniwien.ac.at.
Stefan TraussniggDivision of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. stefan.traussnigg@meduniwien.ac.at.
Tanja WürgerDepartment of Pathology, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. tanja.wuerger@meduniwien.ac.at.
Karin SchindlerDivision of Endocrinology and Metabolism, Department of Internal Medicine III, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. karin.schindler@meduniwien.ac.at.
Bernhard LudvikDivision of Endocrinology and Metabolism, Department of Internal Medicine III, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. bernhard.ludvik@meduniwien.ac.at.
Medical University of Vienna · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBeyond its classical role in calcium homoeostasis and bone metabolism, vitamin D deficiency has been found to be associated with several diseases, including diabetes, non-alcoholic fatty liver disease, and even obesity itself. Importantly, there are limited data on therapeutic strategies for vitamin D deficiency in bariatric patients, and the procedure-specific guidelines may not be sufficient. To improve long-term outcomes, nutritional screening and appropriate supplementation to prevent nutrient deficiencies are urgently needed. Therefore, the aim of this study is to examine effects and safety of a forced dosing regimen of vitamin D versus conventional dose supplementation on vitamin D levels and other parameters in bariatric patients. METHODS/

designThe study includes loading plus repeat dosing compared with repeated administration of vitamin D without a loading dose, according to guidelines, in a prospective, double-blind, randomized controlled trial. Up to a triple oral loading dose is given on day 1, then 2 and 4 weeks after surgery (100,000 IU dose each time), followed by an oral maintenance dose (3420 IU/day). The control group (n = 25) will receive placebo, followed by administration of a standard dose (3420 IU/day). We hypothesize that a significant increase in vitamin D levels will occur in patients in the treatment group (n = 25) by 24 weeks after surgery. Further measurements are aimed at evaluating changes in inflammation, bone turnover, insulin resistance, blood pressure, liver, mental health, and gut microbiota of patients undergoing omega-loop gastric bypass surgery. Furthermore, possible associations between concentrations of vitamin D, the involved enzymes, or vitamin D receptor in adipose and/or liver tissues will be determined. DISCUSSION: To our knowledge, this trial is the first of its kind with this type of vitamin D supplementation in bariatric patients. Its major strength is the design and implementation of evaluation of influencing factors such as liver function, bone health, inflammation, insulin resistance, blood pressure, symptoms of depression, or microbiota. This alternative vitamin D dosing regimen has the potential to be a safe, fast, evidence-based treatment of vitamin D deficiency in bariatric patients. Owing to the increasing number of bariatric patients, it is also of interest to elucidate the link between obesity and vitamin D.

trial registrationClinicalTrials.gov identifier: NCT02092376 . Registered on 17 March 2014.

Indexed as

Dietary SupplementsAdministration, OralBiomarkersCholecalciferolClinical ProtocolsDouble-Blind MethodDrug Administration ScheduleFemaleGastric BypassHumansMaleObesityPostoperative CareProspective StudiesResearch DesignTime Factors25-hydroxyvitamin DBiomarkersCholecalciferolVitamin D

Identifiers

PMID26242295
PMCPMC4524369
OpenAlexW1852889414

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.