Evaluation of the Absorption Rate From Different Oral Fe-supplements in Obese Volunteers Pre- and Post-RYGB
2 other identifiers
interventional
15
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Oct 2015
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 5, 2015
CompletedFirst Posted
Study publicly available on registry
October 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedMay 18, 2017
May 1, 2017
2.2 years
October 5, 2015
May 17, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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.
One year
Study Arms (1)
RYGB-patient
OTHERPatients 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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%)
You may not qualify if:
- Patients with a bariatric surgery history
- Smokers (\> 15 cigarettes/day)
- Pregnant women
- Lactating women
- Patients with a positive helicobacter pylori screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KU Leuvenlead
Study Sites (1)
University Hospitals Leuven
Leuven, 3000, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bart Van der Schueren
KU Leuven
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PharmD-PhD
Study Record Dates
First Submitted
October 5, 2015
First Posted
October 7, 2015
Study Start
October 1, 2015
Primary Completion
December 1, 2017
Study Completion
August 1, 2018
Last Updated
May 18, 2017
Record last verified: 2017-05