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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
Sponsor:
Information provided by (Responsible Party):
Ina Gesquiere, KU Leuven

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Iron supplements, more specific Ferrodyn and Vista Ferrum Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
RYGB-patient
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Obese patients who have planned a RYGB surgery in the University Hospital Leuven
  • Low iron status at the preoperative consultation (ferritin < 30 µg/L and/or transferrin saturation <20%)

Exclusion Criteria:

  • Patients with a bariatric surgery history
  • Smokers (> 15 cigarettes/day)
  • Pregnant women
  • Lactating women
  • Patients with a positive helicobacter pylori screening

Information from the National Library of Medicine

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


Contacts
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Contact: Ina Gesquiere 0032 016 37 72 32 ina.gesquiere@pharm.kuleuven.be
Contact: Nele Steenackers nele.steenackers@student.kuleuven.be

Locations
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Belgium
University Hospitals Leuven Recruiting
Leuven, Belgium, 3000
Contact: Ina Gesquiere, PharmD,PhD    +32 16 37 72 32    ina.gesquiere@kuleuven.be   
Sponsors and Collaborators
KU Leuven
Investigators
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Principal Investigator: Bart Van der Schueren KU Leuven
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Responsible Party: Ina Gesquiere, PharmD-PhD, KU Leuven
ClinicalTrials.gov Identifier: NCT02569593    
Other Study ID Numbers: IAS15
s58442 ( Other Identifier: Clinical Trial Center UZ )
First Posted: October 7, 2015    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: May 2017