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Liposoluble vitamins in patients receiving longterm treatment with octreotide.


- candidate number5466
- NTR NumberNTR1730
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-mrt-2009
- Secondary IDs2008/286 MEC Groningen
- Public TitleLiposoluble vitamins in patients receiving longterm treatment with octreotide.
- Scientific TitleLiposoluble vitamins in patients receiving long-term octreotide treatment.
- ACRONYMN/A
- hypothesisThere 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.
- Healt Condition(s) or Problem(s) studiedLiposoluble vitamin deficiency, Carcinoid tumour, Acromegalia
- Inclusion criteriaPatients 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.
- Exclusion criteriaNo informed consent, age less then 18 years.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jan-2009
- planned closingdate1-dec-2009
- Target number of participants80
- InterventionsN/A
- Primary outcome1. Liposoluble vitamins;
2. Relevant lipid components;
3. Relevant biochemical investigations to measure effects of possible vitamin deficiency, including calcium levels, PTH and coagulation.
- Secondary outcomeN/A
- TimepointsThis investigation will be done by blood analysis at one time point.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES H.B. Fiebrich
- CONTACT for SCIENTIFIC QUERIESProf.dr. E.G.E. Vries, de
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsN/A
- Brief summaryThis is a cross-sectional explorative cohort study in patients receiving long-term octreotide treatment (longer than 18 months) for acromegaly or a carcinoid tumour. Patients will be investigated for vitamin-status at one time point. 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 patientís health.

Single-center studie in Groningen, the Netherlands
- Main changes (audit trail)
- RECORD17-mrt-2009 - 14-sep-2009


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