To determine the frequency and severity of liposoluble vitamin malabsorption side effects of long term octreotide treatment and/or small bowel resection
ID
Source
Brief title
Condition
- Vitamin related disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Patients will be investigated for vitamin-status by measuring liposoluble
vitamins, relevant lipid components and relevant biochemical investigations to
measure effects of possible vitamin deficiency, including calciumlevels, PTH
and coagulation in blood
Secondary outcome
-
Background summary
Long-term octreotide therapy is an important medical treatment to control
symptoms of hypersecretion of biological active amines and peptides in a number
of diseases, such as acromegaly or carcinoid tumours. Side effects of
octreotide treatment are usually acceptable and often passing. Octreotdide is
registered for clinical use since 1989, while the now commonly used long-acting
form became available in 1997.
There is some evidence pointing towards a risk liposoluble vitamin deficiency
in patients receiving long-term octreotide treatment. This is becoming clear
only recently as there are now patients using this drug since it became
available. Groups especially using octreotide are acormegaly patients and
patients with carcinoid, who have as additional reason for vitamin deficiency
the fact that often a part of the small bowel is resected. However, vitamin
status is not routinely assessed in these patients, even though vitamin
deficiency can seriously affect quality of life.
Study objective
To determine the frequency and severity of liposoluble vitamin malabsorption
side effects of long term octreotide treatment and/or small bowel resection
Study design
This is a cross-sectional explorative cohort study in patients receiving
long-term octreotide treatment for acromegaly or a carcinoid tumour. Patients
are eligible when they have used octreotide for at least 18 months. Patients
must be 18 years or older and must be willing to give written informed consent
This investigation will be done by blood analysis at one time point
Study burden and risks
The blood analysis will be performed during routine outpatient visits, when
regular blood samples are drawn. No serious adverse events are linked to the
described study procedures. With this study we hope to get insight into the
frequency and severity of deficiency of liposoluble vitamins in patients
receiving long-term octreotide therapy. This will contribute to the early
recognition and suppletion of (sub)clinical deficiencies thus improving
patient*s health.
Hanzeplein 1
9713 GZ Groningen
Nederland
Hanzeplein 1
9713 GZ Groningen
Nederland
Listed location countries
Age
Inclusion criteria
octreotide-treatment longer than 18 months
Exclusion criteria
-
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL25367.042.08 |