ObesityNCT02569593
Evaluation of the Absorption Rate From Different Oral Fe-supplements in Obese Volunteers Pre- and Post-RYGB
A study testing Iron supplements, more specific Ferrodyn and Vista Ferrum in people with Obesity, run by KU Leuven at 1 site in Belgium.
Trial summary
Obese volunteers who have scheduled a gastric bypass (RYGB) in UZ Leuven will be asked to participate in a cross-over study using commercial available iron supplements. The aim of this study is to evaluate the absorption rate of different oral iron supplements in volunteers before and after RYGB (1, 3, 6 and 12 months… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Iron supplements, more specific Ferrodyn and Vista Ferrum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2015to Aug 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obese patients who have planned a RYGB surgery in the University Hospital Leuven
- Low iron status at the preoperative consultation (ferritin < 30 µg/L and/or transferrin saturation <20%)
Who cannot join
- Patients with a bariatric surgery history
- Smokers (> 15 cigarettes/day)
- Pregnant women
- Lactating women
- Patients with a positive helicobacter pylori screening
Trial locations and contacts
1 site in 1 country.
Nele Steenackers contact
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven
Leuven, 3000
Ina Gesquiere, PharmD,PhD, +32 16 37 72 32, ina.gesquiere@kuleuven.be
About this study
Official title: Evaluation of the Absorption Rate From Different Oral Fe-supplements in Obese Volunteers Pre- and Post-RYGB: an Interventional Study
Obese volunteers who have scheduled a gastric bypass (RYGB) in UZ Leuven will be asked to participate in a cross-over study using commercial available iron supplements. The aim of this study is to evaluate the absorption rate of different oral iron supplements in volunteers before and after RYGB (1, 3, 6 and 12 months post-RYGB).
Read the detailed description
Patients who met the criteria will be invited to come to the clinical research center at 10 occasions (two times before and 1, 3, 6 and 12 months after RYGB). During each visit the following information will be collected:
- General information concerning sociodemographic and medical background
- The medical history
- Anthropometric measures
- Physical activity by questionnaire
- Food frequency by questionnaire
- Information about menstrual blood loss.
Following an overnight fast, subjects will come to the clinical research center. An intravenous catheter will be inserted to collect blood samples. Before the oral administration, blood samples will be collected for the determination of the serum concentration of different iron status markers. The volunteers will receive first an iron(II)sulfate supplement, followed by a Fe-chelate supplement (at least 7 days between both supplements). After the administration of the supplement, blood samples will be taken at various time points to determine the amount of iron absorption and to investigate if there are any changes in the iron metabolism (at 15, 30, 60, 90 minutes and 2; 2.5; 3; 3.5; 4 and 5 hours after oral administration). There will be a one-week washout period between the tests with each iron supplement. The volunteers will be asked to repeat the test before surgery and 1, 3, 6 and 12 months after surgery for each iron supplement.
- Conditions
- Obesity
- Being tested
- Iron supplements, more specific Ferrodyn and Vista Ferrum
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron supplements, more specific Ferrodyn and Vista FerrumDietary supplement
Ferrodyn is an Fe-chelate supplement. One tablet contains 28 mg elemental iron. Vista Ferrum is an iron(II)sulfate supplement. One tablet also contains 28 mg elemental iron. The volunteers will be asked to take the provided supplement orally with 150 mL of water.
| Study group | Role | What they receive |
|---|---|---|
| RYGB-patient | Other | Patients with a planned RYGB at UZ Leuven will be recruited. Iron supplements, more specific Ferrodyn and Vista Ferrum will be administrated in these patients before and 1, 3, 6 and 12 months post-RYGB with at least 7 days between the administration of the different supplements. Receives: Dietary Supplement: Iron supplements, more specific Ferrodyn and Vista Ferrum |
What is being measured
The primary outcome is the main question the study is designed to answer.
The absorption rate from different oral Fe-supplements
The rate and extent of absorption of iron wille be estimated by changes in serum iron concentration.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2017 (estimated)
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ina Gesquiere, KU Leuven
- Investigators
- Bart Van der Schueren, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02569593
- Sponsor's protocol ID
- IAS15
- Other IDs
- s58442
- Status last verified
- May 2017
- First submitted
- 5 Oct 2015
- Last updated
- 18 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Absorption Rate From Different Oral Fe-supplements in Obese Volunteers Pre- and Post-RYGB: an Interventional Study
- ClinicalTrials.gov ID
- NCT02569593
- Acronym / sponsor ID
- IAS15
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Aug 2018
- First posted
- 7 Oct 2015 (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.
Obese volunteers who have scheduled a gastric bypass (RYGB) in UZ Leuven will be asked to participate in a cross-over study using commercial available iron supplements. The aim of this study is to evaluate the absorption rate of different oral iron supplements in volunteers before and after RYGB (1, 3, 6 and 12 months post-RYGB).
Detailed description
Patients who met the criteria will be invited to come to the clinical research center at 10 occasions (two times before and 1, 3, 6 and 12 months after RYGB). During each visit the following information will be collected:
- General information concerning sociodemographic and medical background
- The medical history
- Anthropometric measures
- Physical activity by questionnaire
- Food frequency by questionnaire
- Information about menstrual blood loss.
Following an overnight fast, subjects will come to the clinical research center. An intravenous catheter will be inserted to collect blood samples. Before the oral administration, blood samples will be collected for the determination of the serum concentration of different iron status markers. The volunteers will receive first an iron(II)sulfate supplement, followed by a Fe-chelate supplement (at least 7 days between both supplements). After the administration of the supplement, blood samples will be taken at various time points to determine the amount of iron absorption and to investigate if there are any changes in the iron metabolism (at 15, 30, 60, 90 minutes and 2; 2.5; 3; 3.5; 4 and 5 hours after oral administration). There will be a one-week washout period between the tests with each iron supplement. The volunteers will be asked to repeat the test before surgery and 1, 3, 6 and 12 months after surgery for each iron supplement.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RYGB-patient | Other | Dietary Supplement: Iron supplements, more specific Ferrodyn and Vista FerrumPatients with a planned RYGB at UZ Leuven will be recruited. Iron supplements, more specific Ferrodyn and Vista Ferrum will be administrated in these patients before and 1, 3, 6 and 12 months post-RYGB with at least 7 days between the administration of the different supplements. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Obese patients who have planned a RYGB surgery in the University Hospital Leuven
- Low iron status at the preoperative consultation (ferritin < 30 µg/L and/or transferrin saturation <20%)
Key exclusion criteria (5 listed)
- Patients with a bariatric surgery history
- Smokers (> 15 cigarettes/day)
- Pregnant women
- Lactating women
- Patients with a positive helicobacter pylori screening
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 |
|---|---|---|
| Iron supplements, more specific Ferrodyn and Vista FerrumFerrodyn is an Fe-chelate supplement. One tablet contains 28 mg elemental iron. Vista Ferrum is an iron(II)sulfate supplement. One tablet also contains 28 mg elemental iron. The volunteers will be asked to take the provided supplement orally with 150 mL of water. | Dietary supplement | RYGB-patient |
Primary outcome
The absorption rate from different oral Fe-supplements
Time frame: One year
The rate and extent of absorption of iron wille be estimated by changes in serum iron concentration.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2017.
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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.
Nele Steenackers contact
Bart Van der Schueren principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron supplements, more specific Ferrodyn and Vista Ferrum in people with Obesity, run by KU Leuven at 1 site in Belgium.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 18 May 2017. 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 Belgium. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ina Gesquiere (0032 016 37 72 32, ina.gesquiere@pharm.kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The absorption rate from different oral Fe-supplements (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2017.