The main objective is to optimize the supplementation of vitamins and minerals to prevent postoperative deficiencies after MB / RYGB or GS on the long term. We also examined whether the number of outpatient visits, blood tests, and costs can be…
ID
Source
Brief title
Condition
- Vitamin related disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number of vitamin deficiencies
Number of outpatient visits per patient
Reduction in number of vitamin B12 deficiencies after treatment with
multivitamin tablets.
For precise details, see the research (Chapter 4 aims of the study)
Secondary outcome
For precise details, see the research (Chapter 4 aims of the study)
Background summary
The number of bariatric surgeries has increased the past decades. There are
several types of bariatric surgery; the most important are the gastric band,
Gastric Sleeve and Roux - en-Y Gastric Bypass ( RYGB ). The RYGB is in our
centre the most common type of bariatric surgery. The effect of the RYGB is a
combination between malabsorption and restriction. In addition to the benefits
that entails RYGB (weight reduction, improvement of co-morbidities, improved
quality of life, etc. ) there are also disadvantages, including vitamin
deficiencies. Despite the advice to use 150% RDA of multivitamins, additional
supplementation of in particular iron, vitamin B12 , Folic Acid , Vitamin D and
Calcium are necessary. Almost 40% of the postoperative bariatric patients who
visit our outpatient department are coming for examination or treatment of a
vitamin or mineral deficiency. Any reduction in the number of deficiencies
would not only reduce the morbidity of the patients but also the pressure on
postoperative outpatient clinic. Based on literature on vitamin and mineral
deficiencies a specifically multivitamin was developed for patients with
Gastric Band, GS and RYGB . This multivitamin is freely available to all
patients since 2010. In this multivitamin, the proportions of vitamins are
adjusted so that the risk of shortages should be reduced and high values should
be avoided.
Study objective
The main objective is to optimize the supplementation of vitamins and minerals
to prevent postoperative deficiencies after MB / RYGB or GS on the long term.
We also examined whether the number of outpatient visits, blood tests, and
costs can be reduced. Finally, this study compares the effect multivitamin
tablets and vitamine B12 injections on the development of vitamin B12
deficiencies. For precise details, see the researchprotocol (Chapter 4 aims of
the study)
Study design
The majority of the study will be retrospectively on patients who underwent in
the past MB / gastric sleeve or RYGB.
The treatment of vitamin B12 deficiencies with tablets or injections
(hydroxocobalamin) will be done prospectively.
For precise details, see the researchprotocol (Chapter 5 methods)
Study burden and risks
All visits will be within the regular care as that comes standard after
bariatric surgery.
Wagnerlaan 55
Arnhem 6800TA
NL
Wagnerlaan 55
Arnhem 6800TA
NL
Listed location countries
Age
Inclusion criteria
Patients who underwent RYGB;Patients who developed a vitamin B12 deficiency postoperatively
Exclusion criteria
Creatinine> 150 micromol / L;Liver enzymes> 2 times the upper limit;Previous operations on the gastrointestinal tract (except RYGB);Intercurrerende disease;Gastrointestinal disease;psychiatric illness;known pregnancy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-004835-60-NL |
| CCMO | NL47058.091.13 |