Iron AbsorptionPhase 4NCT02228902
Iron Absorption Trial
A Phase 4 study testing Ferrous fumarate and Ferrous gluconate in people with Iron Absorption and Bariatric Surgery, run by Rijnstate Hospital at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Iron Absorption, Bariatric Surgery, Roux- en -y Gastric Bypass
- What is being tested?
- Ferrous fumarate and Ferrous gluconate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2014to 4 May 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Being tested
- Ferrous fumarate, Ferrous gluconate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous fumarateDrug
one group receives ferrous fumarate (12 patients) and one group (12 patients) receives ferrous gluconate
Ferrous gluconateDrug
Also called Losferron
One group receives ferrous fumarate and one group receives ferrous fumarate.
| Study group | Role | What they receive |
|---|---|---|
| ferrous fumarate | Active comparator | 12 patients receive ferrous fumarate, 12 patients receive ferrous gluconate Receives: Drug: Ferrous fumarate |
| ferrous gluconate | Active comparator | 12 patients receive ferrous fumarate and 12 patients receive ferrous gluconate Receives: Drug: Ferrous gluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month after surgery
Secondary outcomes (1)
difference in absorption between ferrous fumarate and ferrous gluconate
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionMay 2015
- Study completion4 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron AbsorptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228902
- Sponsor's protocol ID
- Ironabsorption
- Status last verified
- Jun 2020
- First submitted
- 13 Aug 2014
- Last updated
- 11 Jun 2020
- Results posted
- No
Publications
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.
PubMed 29327182
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Absorption Trial
- ClinicalTrials.gov ID
- NCT02228902
- Acronym / sponsor ID
- Ironabsorption
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- 4 May 2015 (actual)
- First posted
- 29 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ferrous fumarate | Active comparator | Drug: Ferrous fumarate12 patients receive ferrous fumarate, 12 patients receive ferrous gluconate |
| ferrous gluconate | Active comparator | Drug: Ferrous gluconate12 patients receive ferrous fumarate and 12 patients receive ferrous gluconate |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferrous fumarateone group receives ferrous fumarate (12 patients) and one group (12 patients) receives ferrous gluconate | Drug | ferrous fumarate |
| Ferrous gluconateAlso: LosferronOne group receives ferrous fumarate and one group receives ferrous fumarate. | Drug | ferrous gluconate |
Primary outcome
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 secondary outcome
difference in absorption between ferrous fumarate and ferrous gluconate
Time frame: 1 month after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Derived from this study: PubMed 29327182Schijns 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.
Related trials for Iron Absorption
Active, not recruitingObservational study
Ethnic Differences in Iron Absorption (FeGenes)
Anemia, Iron Deficiency, Iron Overload
Active, not recruitingObservational study
Heme and Non-heme Iron Intakes, Gut Microbiota, and Influence on Host Iron Absorption
Anemia, Iron Deficiency, Iron Overload
RecruitingObservational study
Long-term Iron Absorption and Loss in Women
Obesity & Overweight, Normal Weight Adults
Active, not recruiting
The Effects of Acute Erythropoietin on Hepcidin and Dietary Iron Absorption Following Military-relevant Exercise in Energy Deficit: Pilot Study
Iron Absorption
Active, not recruitingObservational study
Iron Absorption From Lipid-Based Nutrient Supplements
Undernutrition, Healthy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferrous fumarate and Ferrous gluconate in people with Iron Absorption and Bariatric Surgery, run by Rijnstate Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iron values in the blood (time frame: 1 month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02228902, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.