NCT02228902

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 29, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2015

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

9 months

First QC Date

August 13, 2014

Last Update Submit

June 8, 2020

Conditions

Iron AbsorptionBariatric SurgeryRoux- en -y Gastric Bypass

Outcome Measures

Primary Outcomes (1)

  • Iron values in the blood

    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 Outcomes (1)

  • difference in absorption between ferrous fumarate and ferrous gluconate

    1 month after surgery

Study Arms (2)

ferrous fumarate

ACTIVE COMPARATOR

12 patients receive ferrous fumarate, 12 patients receive ferrous gluconate

Drug: Ferrous fumarate

ferrous gluconate

ACTIVE COMPARATOR

12 patients receive ferrous fumarate and 12 patients receive ferrous gluconate

Drug: Ferrous gluconate

Interventions

Ferrous fumarateDRUG

one group receives ferrous fumarate (12 patients) and one group (12 patients) receives ferrous gluconate

ferrous fumarate
Ferrous gluconateDRUG

One group receives ferrous fumarate and one group receives ferrous fumarate.

Also known as: Losferron
ferrous gluconate

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rijnstate hospital

Arnhem, 6800WC, Netherlands

Location

Related Publications (1)

  • Schijns W, Ligthart MAP, Berends FJ, Janssen IMC, van Laarhoven CJHM, Aarts EO, de Boer H. Changes in Iron Absorption After Roux-en-Y Gastric Bypass. Obes Surg. 2018 Jun;28(6):1738-1744. doi: 10.1007/s11695-017-3088-5.

    PMID: 29327182DERIVED

MeSH Terms

Interventions

ferrous fumarateferrous gluconate

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2014

First Posted

August 29, 2014

Study Start

August 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 4, 2015

Last Updated

June 11, 2020

Record last verified: 2020-06

Locations

NL(1)