Optimizing Iron Suppletion After Roux-en-Y Gastric Bypass
Ironsuppletion
1 other identifier
interventional
120
1 country
3
Brief Summary
Multicentre randomized controlled trial to evaluate the optimal treatment for patients who developed an iron deficiency after Roux-en-Y Gastric bypass.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2014
Typical duration for phase_4
3 active sites
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
First Submitted
Initial submission to the registry
October 20, 2014
CompletedFirst Posted
Study publicly available on registry
October 22, 2014
CompletedStudy Start
First participant enrolled
December 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 6, 2017
CompletedJanuary 18, 2019
January 1, 2019
2.5 years
October 20, 2014
January 16, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
normal value serum ferritin
1 year after initiating therapy
1 year
Secondary Outcomes (1)
patients preference for oral or intravenous therapy
1 year
Study Arms (3)
Ferrous fumarate
ACTIVE COMPARATOR40 patients receive ferrous fumarate 3 times a day 200mg
Ferrous gluconate
ACTIVE COMPARATOR40 patients receive ferrous gluconate 2 times a day 695 mg
Iron(III)carboxymaltose
ACTIVE COMPARATOR40 patients receive a single intravenous shot of ferinject
Interventions
treatment with ferrous fumarate during 1 year and 6,12,26 and 52 weeks after starting treatment iron spectrum will be measured
treatment with ferrous gluconate during 1 year and 6,12,26 and 52 weeks after starting treatment iron spectrum will be measured
treatment with Iron(III)carboxymaltose and 6,12,26 and 52 weeks after starting treatment iron spectrum will be measured
Eligibility Criteria
You may qualify if:
- all women who underwent a Roux-en-Y gastric bypass and developed an iron deficiency postoperatively (ferritin\<20microgram/L)
You may not qualify if:
- iron deficiency peroperative, blood transfusions during study period, iron containing nutritional supplements except the standard multivitamins after bariatric surgery, decreased renal failure, excessive blood loss due to menstruation, anemia not caused by iron deficiency, accumulation of iron, hypersensitivity for noe of the medicinal products, psychiatric illness, pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
OLVG West/ Sint Lucas Andreas Ziekenhuis
Amsterdam, North Holland, 1061 AE, Netherlands
Rijnstate hospital
Arnhem, 6800WC, Netherlands
Rose Kruis Ziekenhuis
Beverwijk, Netherlands
Related Publications (1)
Schijns W, Boerboom A, de Bruyn Kops M, de Raaff C, van Wagensveld B, Berends FJ, Janssen IMC, van Laarhoven CJHM, de Boer H, Aarts EO. A randomized controlled trial comparing oral and intravenous iron supplementation after Roux-en-Y gastric bypass surgery. Clin Nutr. 2020 Dec;39(12):3779-3785. doi: 10.1016/j.clnu.2020.04.010. Epub 2020 Apr 21.
PMID: 32402684DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2014
First Posted
October 22, 2014
Study Start
December 4, 2014
Primary Completion
June 6, 2017
Study Completion
June 6, 2017
Last Updated
January 18, 2019
Record last verified: 2019-01