Vitamine suppletion by morbide obase patient

International literature provides many recommendations about the optimal
treatment and prevention of several common deficiencies in vitamins and
minerals. Unfortunately, these opinions are often limited to a small number of
examined nutrients and turn them into practice in many patients not enough.
On the basis of evidence-based literature on vitamins and minerals, a
manufacturer produced a multivitamin specifically designed for patients with a
gastric band or a RYGB. In these preparations, the proportions are adjusted so
that the risk of shortages should decrease and on the other hand, too high in
nutrients should be avoided.

Optimization of the supplementation of vitamins and minerals
1. In patients who received a gastric banding for treatment for their morbid
obesity
a. Reduction of iron deficiency
b. Reduction of Vitamin B12 deficiency
c. Reduced Vitamin D deficiency

2. In patients with a RYGB to undergo treatment for their morbid obesity
a. Reduction of iron deficiency
b. Reduction of Vitamin B12 deficiency
c. Reduced Vitamin D deficiency
d. Reduction of Folate deficiency
e. Reduction of calcium deficiency

Start of study;
The manufacturer of the tablets produced 400 sets of multivitamins (each set a
year's supply), each set with a unique number on each box. In total there are:
1. 100 Sets New MVM for the gastric band
2. 100 Sets New MVM for the RYGB
3. 200 Sets Basic MVM for a control group and a control gastric band patients
RYGB patients.

The key to this series is made by the manufacturer, and given to our
independent pharmacist. This pharmacist will be responsible for control and
handout of multivitamins. Interim analysis is performed by the same pharmacist
for every 50 patients who postoperatively have a measurement carried out. The
pharmacist will break the key on these moments and carry out an interim
analysis. If the outcomes are significantly different to high levels of
vitamins or minerals are found (above normal) it will immediately be fed back
to both the principal investigator. The latter is however not expected.

Pre-operative patients:
Two weeks prior to the information session for operation that patients receive
3 months for their operation the patient is contacted by telephone by the
attending surgeon. If the patient is positive about the study, the patient will
receive more information by letter.
At the information session the patient has a personal conversation with his
surgeon. At present, the patient is asked whether he wishes to participate in
the study and asked to sign an Informed Consent (IC) (in duplicate). At the
CRF, the basic data of the patient are recorded. From this point the patient
will be considered included and receives a number which corresponds to a set of
multivitamins. In total, four groups emerge as:

Group 1: Banding with MVM's new
Group 2: Banding with MVM's current
Group 3: RYGB with MVM's new
Group 4: RYGB with MVM's current

The same day the standard preoperative lab will be withdrawn.
If there are deficits or other abnormalities are found, patients are seen by
the endocrinologist. This will be the patients preoperatively suppletion to
make up a normal level.

Operation:
On the day of surgery only weight is recorded, operative time and blood loss
and possible complications

6 Months control
During this audit, patients will get another set of multivitamins for their
second half year. In addition, there is a fasting blood test done. Also this is
a regular blood test. On the CRFs are the current weight, Fat%, medication and
decrease co-morbidity recorded
If there are deficits or other abnormalities are found, patients are seen by
the endocrinologist. This will be the patients preoperatively suppletion to
make up a normal level.

12 Months Control
This control is similar to that of 6 months. According to standard protocol a
blood test is done. CRFs are the current weight, Fat%, medication and decrease
co-morbidity recorded
If there are deficits or other abnormalities are found, patients are seen by
the endocrinologist. This will be the patients preoperatively suppletion to
make up a normal level.

Besides these studies, we will keep track of what the cost in terms of
correcting deficiencies. This will be a cost-benefit analysis

Standard multivitamin vs. optimal multivitamin

Burden; Patient must complete a questionnaire three times (3 times 5 minutes).

Risks; too high levels of vitamins and minerals. However, this risk is lower
than when using regular multivitamins. In addition, patients frequently pinned
to verify this
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