Iron Absorption Trial

June 8, 2020 updated by: Rijnstate Hospital

Introduction: There are indications that the absorption of oral iron supplementation is reduced after a Roux- en -Y gastric bypass. Nevertheless, oral preparations are used as standard therapy for iron deficiency, even in patients who underwent a Roux- en -Y gastric bypass. Our goal is to evaluate if iron absorption is disturbed after a RYGB, which leads to a insufficient treatment of oral iron suppletion.

Methods: an iron absorption test will be performed pre- and postoperatively in 24 patients. Two groups will be created.

Preoperatively group 1 receives a daily dose of ferrous fumarate (600mg) and group 2 receives a daily dose Losferron (1390mg).

Before intake of the medicines, a fasting blood sample is taken (baseline), serum iron including ferritin, transferrin and transferrin saturation will be measured. After intake of losferron/ferrous fumarate blood samples will be taken 1, 2, 3, 4, 5 and 6 hours after intake, using a drip. An increase of 80 microgram/l is representative for a sufficient iron absorption. All patients undergo a Roux- en -Y gastric bypass.

Postoperatively; one month postoperatively the same absorption test will be repeated in the same patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Arnhem, Netherlands, 6800WC
        • Rijnstate Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients who are eligible for a primary Roux- en -Y gastric bypass and who have no pre-existing iron deficiency (serum ferritin between 20-200 micrograms/L)

Exclusion Criteria:

  • blood transfusion one month before ans in the study period. The use of iron containing nutritional supplements, except our standardized multivitamin supplements. Decreased function of the kidney with a GFR of < 30ml/min and a serum creatinin below 50 micromol/L. Hb< 7.4 mmol/L in females en Hb< 8.4 mmol/L in males. Accumulation of iron. Hypersensitivity for ons of the medicinal products. Psychiatric illness. Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ferrous fumarate
12 patients receive ferrous fumarate, 12 patients receive ferrous gluconate
Drug: Ferrous fumarate
one group receives ferrous fumarate (12 patients) and one group (12 patients) receives ferrous gluconate
Active Comparator: ferrous gluconate
12 patients receive ferrous fumarate and 12 patients receive ferrous gluconate
Drug: Ferrous gluconate
One group receives ferrous fumarate and one group receives ferrous fumarate.
Other Names:
  • Losferron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Iron values in the blood
Time Frame: 1 month after surgery
Iron levels in teh blood will be measured before and 1,2,3,4,5 and 6 hours after the administration of oral iron replacement in micrograms / dl. This will take place before surgery and one month after surgery. The primary outcome is de difference between iron values pre- and postoperatively.
1 month after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
difference in absorption between ferrous fumarate and ferrous gluconate
Time Frame: 1 month after surgery
1 month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rijnstate Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 4, 2015

Study Registration Dates

First Submitted

August 13, 2014

First Submitted That Met QC Criteria

August 27, 2014

First Posted (Estimate)

August 29, 2014

Study Record Updates

Last Update Posted (Actual)

June 11, 2020

Last Update Submitted That Met QC Criteria

June 8, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ironabsorption

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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