Evidence map›Paper›PMID 31776782›Full record

Trial reportObesity surgery2020

The True Story on Deficiencies After Sleeve Gastrectomy: Results of a Double-Blind RCT.

Laura Heusschen, Wendy Schijns, Nadine Ploeger, Laura N Deden, Eric J Hazebroek, Frits J Berends, Edo O Aarts

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Obesity surgery, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01609387 (Postoperative Vitamin Supplementation in Morbidly Obese Patient), which is not on this map. Cited by 14 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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.

NCT01609387 phase4completednot on this map

Postoperative Vitamin Supplementation in Morbidly Obese Patient

TypeinterventionalSponsorRijnstate HospitalRan2011 to 2015Enrolled300ConditionsObesity, Vitamin DeficiencyArmsFit For me, Davitamon
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Article
  5. Article
  6. Article
  7. Review
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. 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

7 authors.

Laura HeusschenDepartment of Surgery, Vitalys Clinic and Rijnstate Hospital, Wagnerlaan 55, Arnhem, 6800 TA, The Netherlands. LHeusschen@Rijnstate.nl.ORCID 0000-0002-8096-0188
Wendy SchijnsDepartment of Surgery, Vitalys Clinic and Rijnstate Hospital, Wagnerlaan 55, Arnhem, 6800 TA, The Netherlands.
Nadine PloegerDepartment of Surgery, Vitalys Clinic and Rijnstate Hospital, Wagnerlaan 55, Arnhem, 6800 TA, The Netherlands.
Laura N DedenDepartment of Surgery, Vitalys Clinic and Rijnstate Hospital, Wagnerlaan 55, Arnhem, 6800 TA, The Netherlands.
Eric J HazebroekDepartment of Surgery, Vitalys Clinic and Rijnstate Hospital, Wagnerlaan 55, Arnhem, 6800 TA, The Netherlands.
Frits J BerendsDepartment of Surgery, Vitalys Clinic and Rijnstate Hospital, Wagnerlaan 55, Arnhem, 6800 TA, The Netherlands.
Edo O AartsDepartment of Surgery, Vitalys Clinic and Rijnstate Hospital, Wagnerlaan 55, Arnhem, 6800 TA, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSince a few years, the laparoscopic sleeve gastrectomy (SG) has become the most performed bariatric operation worldwide. However, as with all bariatric procedures, SG also leads to vitamin and mineral deficiencies post-operatively and standard multivitamin supplements are probably not sufficient.

objectiveThe present study evaluates the effectiveness of a specialized multivitamin supplement for SG patients (WLS Optimum 1.0, FitForMe, Rotterdam, the Netherlands), compared to a standard multivitamin supplement (sMVS).

designA double-blind randomized controlled trial was performed. For 12 months, patients in the intervention group received WLS Optimum, containing elevated doses of multiple vitamins and minerals. Patients in the control group were provided with sMVS, containing 100% of the recommended dietary allowance.

resultsIn total, 139 patients were available for analysis (WLS Optimum, n = 69; sMVS, n = 70). Intention-to-treat analyses revealed more folic acid deficiencies and higher serum vitamin B1 levels in the WLS Optimum group. Per protocol analyses showed that in patients using WLS Optimum, serum folic acid and vitamin B1 levels were higher, serum PTH levels were lower, and only one patient (2.6%) was anemic compared to 11 patients (17.5%) using a sMVS (p < 0.05 for all). No differences were found in prevalence of deficiencies for iron, vitamin B12, vitamin D, and other vitamins and minerals.

conclusionsThis optimized multivitamin supplement only affected serum levels of folic acid, PTH and vitamin B1, and anemia rates compared to a sMVS. There is a clear need to further optimize multivitamin supplementation for SG patients. Besides, non-compliance with multivitamin supplements remains an important issue that should be dealt with. CLINICAL TRIAL REGISTRY: The study protocol was registered at the clinical trials registry of the National Institutes of Health (ClinicalTrials.gov; identifier NCT01609387).

Indexed as

Obesity, MorbidDietary SupplementsGastrectomyHumansNetherlandsVitaminsVitaminsBariatric surgeryDeficiencies, micronutrients, vitamins, mineralsMorbid obesitySGSleeve gastrectomy

Identifiers

PMID31776782

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.