Iron DeficiencyPhase 4IronsuppletionNCT02271997
Optimizing Iron Suppletion After Roux-en-Y Gastric Bypass
A Phase 4 study testing Ferrous fumarate, Ferrous gluconate and Iron(III)carboxymaltose in people with Iron Deficiency, run by Rijnstate Hospital at 3 sites in Netherlands.
Trial summary
Multicentre randomized controlled trial to evaluate the optimal treatment for patients who developed an iron deficiency after Roux-en-Y Gastric bypass. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Iron Deficiency
- What is being tested?
- Ferrous fumarate, Ferrous gluconate and Iron(III)carboxymaltose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesNetherlands
- Study dates
- 4 Dec 2014to 6 Jun 2017
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all women who underwent a Roux-en-Y gastric bypass and developed an iron deficiency postoperatively (ferritin<20microgram/L)
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
OLVG West/ Sint Lucas Andreas Ziekenhuis
Amsterdam, North Holland, 1061 AE
Rijnstate hospital
Arnhem, 6800WC
Rose Kruis Ziekenhuis
Beverwijk
About this study
Multicentre randomized controlled trial to evaluate the optimal treatment for patients who developed an iron deficiency after Roux-en-Y Gastric bypass.
Read the detailed description
Morbid obesity is worldwide a still growing problem. The number of bariatric procedures are still increasing with 9000 bariatric operations in 2009. The golden standard is the Roux-en-Y Gastric bypass (RYGB). The RYGB ensures an excess weight loss of 60-70% in our hospital.
Unfortunately vitamin and mineral deficiencies are a consequence from RYGB. Iron deficiency occurs in 14-66% in the first two years after surgery. Worldwide there are three most used options of treatment for this: treatment with ferrous fumarate, ferrous gluconate and intravenous injection of Ferinject.
Our goal is to determine which treatment is the most effective to normalize ferritin values in the blood and which treatment is the most cost-effective one after a RYGB.
- Conditions
- Iron Deficiency
- Being tested
- Ferrous fumarate, Ferrous gluconate, Iron(III)carboxymaltose
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous fumarateDrug
treatment with ferrous fumarate during 1 year and 6,12,26 and 52 weeks after starting treatment iron spectrum will be measured
Ferrous gluconateDrug
Also called Losferron
treatment with ferrous gluconate during 1 year and 6,12,26 and 52 weeks after starting treatment iron spectrum will be measured
Iron(III)carboxymaltoseDrug
Also called Ferinject
treatment with Iron(III)carboxymaltose and 6,12,26 and 52 weeks after starting treatment iron spectrum will be measured
| Study group | Role | What they receive |
|---|---|---|
| Ferrous fumarate | Active comparator | 40 patients receive ferrous fumarate 3 times a day 200mg Receives: Drug: Ferrous fumarate |
| Ferrous gluconate | Active comparator | 40 patients receive ferrous gluconate 2 times a day 695 mg Receives: Drug: Ferrous gluconate |
| Iron(III)carboxymaltose | Active comparator | 40 patients receive a single intravenous shot of ferinject Receives: Drug: Iron(III)carboxymaltose |
What is being measured
The primary outcome is the main question the study is designed to answer.
normal value serum ferritin
1 year after initiating therapy
Measured: 1 year
Secondary outcomes (1)
patients preference for oral or intravenous therapy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study start4 Dec 2014
- Primary completion6 Jun 2017
- Study completion6 Jun 2017
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 DeficiencyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 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
- NCT02271997
- Sponsor's protocol ID
- Ironsuppletion
- Acronym
- Ironsuppletion
- Status last verified
- Jan 2019
- First submitted
- 20 Oct 2014
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32402684
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Iron Suppletion After Roux-en-Y Gastric Bypass
- ClinicalTrials.gov ID
- NCT02271997
- Acronym / sponsor ID
- Ironsuppletion / Ironsuppletion
- Conditions
- Iron Deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- 4 Dec 2014 (actual)
- Primary completion
- 6 Jun 2017 (actual)
- Study completion
- 6 Jun 2017 (actual)
- First posted
- 22 Oct 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.
Multicentre randomized controlled trial to evaluate the optimal treatment for patients who developed an iron deficiency after Roux-en-Y Gastric bypass.
Detailed description
Morbid obesity is worldwide a still growing problem. The number of bariatric procedures are still increasing with 9000 bariatric operations in 2009. The golden standard is the Roux-en-Y Gastric bypass (RYGB). The RYGB ensures an excess weight loss of 60-70% in our hospital.
Unfortunately vitamin and mineral deficiencies are a consequence from RYGB. Iron deficiency occurs in 14-66% in the first two years after surgery. Worldwide there are three most used options of treatment for this: treatment with ferrous fumarate, ferrous gluconate and intravenous injection of Ferinject.
Our goal is to determine which treatment is the most effective to normalize ferritin values in the blood and which treatment is the most cost-effective one after a RYGB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ferrous fumarate | Active comparator | Drug: Ferrous fumarate40 patients receive ferrous fumarate 3 times a day 200mg |
| Ferrous gluconate | Active comparator | Drug: Ferrous gluconate40 patients receive ferrous gluconate 2 times a day 695 mg |
| Iron(III)carboxymaltose | Active comparator | Drug: Iron(III)carboxymaltose40 patients receive a single intravenous shot of ferinject |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all women who underwent a Roux-en-Y gastric bypass and developed an iron deficiency postoperatively (ferritin<20microgram/L)
Key exclusion criteria (1 listed)
- 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
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 fumaratetreatment with ferrous fumarate during 1 year and 6,12,26 and 52 weeks after starting treatment iron spectrum will be measured | Drug | Ferrous fumarate |
| Ferrous gluconateAlso: Losferrontreatment with ferrous gluconate during 1 year and 6,12,26 and 52 weeks after starting treatment iron spectrum will be measured | Drug | Ferrous gluconate |
| Iron(III)carboxymaltoseAlso: Ferinjecttreatment with Iron(III)carboxymaltose and 6,12,26 and 52 weeks after starting treatment iron spectrum will be measured | Drug | Iron(III)carboxymaltose |
Primary outcome
normal value serum ferritin
Time frame: 1 year
1 year after initiating therapy
1 secondary outcome
patients preference for oral or intravenous therapy
Time frame: 1 year
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 18 Jan 2019.
- Derived from this study: PubMed 32402684Schijns 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.
- Individual participant dataSharing planned: Undecided
Related trials for Iron Deficiency
Enrolling by invitationObservational study
Long-term Impacts of Psychosocial Stimulation and Iron Supplementation
Iron Deficiency Anemia, Parenting Intervention
Recruiting
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Iron Deficiencies
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The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
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Iron Absorption From IFA and MMS Supplements in Kenyan Women During the Second Trimester of Pregnancy
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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.
3 sites 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, Ferrous gluconate and Iron(III)carboxymaltose in people with Iron Deficiency, run by Rijnstate Hospital at 3 sites 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 18 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
normal value serum ferritin (time frame: 1 year). 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 NCT02271997, 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 18 Jan 2019.