Iron DeficiencyNCT01985386
Iron Absorption From GDS Capsules II
A study testing GDS capsule with meal and Ferrous sulfate with meal in people with Iron Deficiency, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial summary
Slow release iron capsules containing ferrous sulfate have been designed based on the gastric delivery system. Iron absorption from those capsules administered with and without meals will be measured using stable iron isotopes. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency
- What is being tested?
- GDS capsule with meal and Ferrous sulfate with meal
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2013to Jun 2014
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female,
- age 18-50 years,
- max. body weight 65 kg,
- serum ferritin < 30 µg/l
Who cannot join
- pregnancy,
- lactation,
- regular intake of medication,
- blood donation or significant blood losses over the past 4 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Iron Absorption Mechanism From a Slow Release Iron Capsule Using the Gastric Delivery System (Ferrous Sulfate)
Slow release iron capsules containing ferrous sulfate have been designed based on the gastric delivery system. Iron absorption from those capsules administered with and without meals will be measured using stable iron isotopes.
- Conditions
- Iron Deficiency
- Being tested
- GDS capsule with meal, Ferrous sulfate with meal
- Keywords
- Iron absorption, Slow release iron, Gastric delivery system, Iron deficiency
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDS capsule with mealDietary supplement
GDS capsule with meal
Ferrous sulfate with mealDietary supplement
Ferrous sulfate with meal
| Study group | Role | What they receive |
|---|---|---|
| GDS (gastric delivery system), meal | Experimental | GDS capsule with meal Receives: Dietary Supplement: GDS capsule with meal |
| Ferrous sulfate, meal | Active comparator | Ferrous sulfate with meal Receives: Dietary Supplement: Ferrous sulfate with meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional iron absorption
Measured: 2 weeks after test meal consumption
Secondary outcomes (1)
Serum isotope appearance
Measured: 1, 2, 4 and 8 hours on days 1 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
- Investigators
- Isabelle Aeberli, PhD, Principal investigator, ETH Zurich (Switzerland)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01985386
- Sponsor's protocol ID
- EK 2013-N-05-2
- Status last verified
- Jul 2014
- First submitted
- 31 Oct 2013
- Last updated
- 30 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Absorption Mechanism From a Slow Release Iron Capsule Using the Gastric Delivery System (Ferrous Sulfate)
- ClinicalTrials.gov ID
- NCT01985386
- Acronym / sponsor ID
- EK 2013-N-05-2
- Conditions
- Iron Deficiency
- Keywords
- Iron absorption, Slow release iron, Gastric delivery system, Iron deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 15 Nov 2013 (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.
Slow release iron capsules containing ferrous sulfate have been designed based on the gastric delivery system. Iron absorption from those capsules administered with and without meals will be measured using stable iron isotopes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GDS (gastric delivery system), meal | Experimental | Dietary Supplement: GDS capsule with mealGDS capsule with meal |
| Ferrous sulfate, meal | Active comparator | Dietary Supplement: Ferrous sulfate with mealFerrous sulfate with meal |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- female,
- age 18-50 years,
- max. body weight 65 kg,
- serum ferritin < 30 µg/l
Key exclusion criteria (4 listed)
- pregnancy,
- lactation,
- regular intake of medication,
- blood donation or significant blood losses over the past 4 months
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 |
|---|---|---|
| GDS capsule with mealGDS capsule with meal | Dietary supplement | GDS (gastric delivery system), meal |
| Ferrous sulfate with mealFerrous sulfate with meal | Dietary supplement | Ferrous sulfate, meal |
Primary outcome
Fractional iron absorption
Time frame: 2 weeks after test meal consumption
1 secondary outcome
Serum isotope appearance
Time frame: 1, 2, 4 and 8 hours on days 1 and 8
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 30 Jul 2014.
Related trials for Iron Deficiency
Active, not recruiting
A Study to Evaluate the Effects of a Beef Liver Supplement on Energy, Mood, and Mental Clarity
Fatigue, Low Mood
Active, not recruitingObservational study
Heme and Non-heme Iron Intakes, Gut Microbiota, and Influence on Host Iron Absorption
Anemia, Iron Deficiency, Iron Overload
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
Active, not recruitingObservational study
Ethnic Differences in Iron Absorption (FeGenes)
Anemia, Iron Deficiency, Iron Overload
Recruiting
Safety and Efficacy of Iron Prophylaxis With on Iron Homeostasis in Healthy Pregnant Women
Iron Deficiency Anemia in Pregnancy, Iron Deficiency in Pregnancy
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.
Isabelle Aeberli, PhD principal investigator
ETH Zurich (Switzerland)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GDS capsule with meal and Ferrous sulfate with meal in people with Iron Deficiency, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
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 4 inclusion and 4 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 30 Jul 2014. 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 Switzerland. 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?
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?
Fractional iron absorption (time frame: 2 weeks after test meal consumption). 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 30 Jul 2014.