Evaluation of the Absorption Rate From Different Oral Fe-supplements in Obese Volunteers Pre- and Post-RYGB
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02569593|
Recruitment Status : Unknown
Verified May 2017 by Ina Gesquiere, KU Leuven.
Recruitment status was: Recruiting
First Posted : October 7, 2015
Last Update Posted : May 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Dietary Supplement: Iron supplements, more specific Ferrodyn and Vista Ferrum||Not Applicable|
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:
- General information concerning sociodemographic and medical background
- The medical history
- Anthropometric measures
- Physical activity by questionnaire
- Food frequency by questionnaire
- Information about menstrual blood loss.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Evaluation of the Absorption Rate From Different Oral Fe-supplements in Obese Volunteers Pre- and Post-RYGB: an Interventional Study|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||December 2017|
|Study Completion Date :||August 2018|
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 [ Time Frame: One year ]The rate and extent of absorption of iron wille be estimated by changes in serum iron concentration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569593
|Contact: Ina Gesquiere||0032 016 37 72 email@example.com|
|Contact: Nele Steenackersfirstname.lastname@example.org|
|University Hospitals Leuven||Recruiting|
|Leuven, Belgium, 3000|
|Contact: Ina Gesquiere, PharmD,PhD +32 16 37 72 32 email@example.com|
|Principal Investigator:||Bart Van der Schueren||KU Leuven|