Iron Absorption Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-05-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Optimizing Iron Suppletion After Roux-en-Y Gastric Bypass

NCT02271997

Iron Deficiency

COMPLETED PHASE4

Evaluation of the Absorption Rate From Different Oral Fe-supplements in Obese Volunteers Pre- and Post-RYGB

NCT02569593

Obesity

UNKNOWN NA

Fat Absorption and Metabolism After Roux-en-Y Gastric Bypass

NCT04859816

Bariatric Surgery

COMPLETED NA

IV Iron-induced Hypophosphatemia After RYGB

NCT06350955

Hypophosphatemia Roux-en-Y Gastric Bypass

RECRUITING PHASE4

Changes in Gut Hormones, Body Composition and Energy Expenditure After Roux-en-Y

NCT02048501

Obesity Weight Loss

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Iron Absorption Bariatric Surgery Roux- en -y Gastric Bypass

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ferrous fumarate

12 patients receive ferrous fumarate, 12 patients receive ferrous gluconate

Group Type ACTIVE_COMPARATOR

Ferrous fumarate

Intervention Type DRUG

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

ferrous gluconate

12 patients receive ferrous fumarate and 12 patients receive ferrous gluconate

Group Type ACTIVE_COMPARATOR

Ferrous gluconate

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ferrous fumarate

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

Intervention Type DRUG

Ferrous gluconate

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Losferron

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes