An interventional study of Iron supplements, more specific Ferrodyn and Vista Ferrum in Obesity, sponsored by KU Leuven. Status unknown at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-18.
Sponsored by KU Leuven · Not applicable, Interventional, and Supportive care
Obese volunteers who have scheduled a gastric bypass (RYGB) in UZ Leuven will be asked to participate in a cross-over study using commercial available iron supplements. The aim of this study is to evaluate the absorption rate of different oral iron supplements in volunteers before and after RYGB (1, 3, 6 and 12 months post-RYGB).
Patients who met the criteria will be invited to come to the clinical research center at 10 occasions (two times before and 1, 3, 6 and 12 months after RYGB). During each visit the following information will be collected:
Following an overnight fast, subjects will come to the clinical research center. An intravenous catheter will be inserted to collect blood samples. Before the oral administration, blood samples will be collected for the determination of the serum concentration of different iron status markers. The volunteers will receive first an iron(II)sulfate supplement, followed by a Fe-chelate supplement (at least 7 days between both supplements). After the administration of the supplement, blood samples will be taken at various time points to determine the amount of iron absorption and to investigate if there are any changes in the iron metabolism (at 15, 30, 60, 90 minutes and 2; 2.5; 3; 3.5; 4 and 5 hours after oral administration). There will be a one-week washout period between the tests with each iron supplement. The volunteers will be asked to repeat the test before surgery and 1, 3, 6 and 12 months after surgery for each iron supplement.
KU Leuven is the lead sponsor of 358 studies on the registry; 62 are open to participants now.
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Exclusion Criteria:
Patients with a planned RYGB at UZ Leuven will be recruited. Iron supplements, more specific Ferrodyn and Vista Ferrum will be administrated in these patients before and 1, 3, 6 and 12 months post-RYGB with at least 7 days between the administration of the different supplements.
Dietary Supplement: Iron supplements, more specific Ferrodyn and Vista Ferrum
Ferrodyn is an Fe-chelate supplement. One tablet contains 28 mg elemental iron. Vista Ferrum is an iron(II)sulfate supplement. One tablet also contains 28 mg elemental iron. The volunteers will be asked to take the provided supplement orally with 150 mL of water.
The absorption rate from different oral Fe-supplements
The rate and extent of absorption of iron wille be estimated by changes in serum iron concentration.
Time frame: One year
This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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KU Leuven