Iron DeficiencyNCT01874496
Iron Absorption From GDS Capsules
A study testing GDS, no meal and GDS, meal in people with Iron Deficiency, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial summary
Slow release iron capsules 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, no meal and GDS, meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2013to Aug 2013
- 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 < 35µg/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.
Switzerland1 site
Human Nutrition Laboratory, ETH Zurich
Zurich, Canton of Zurich, 8092
About this study
Official title: Iron Absorption Mechanism From a Slow Release Iron Capsule Using the Gastric Delivery System
Slow release iron capsules 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, no meal, GDS, meal, control, no meal, control, meal
- 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, no mealDietary supplement
GDS, no meal
GDS, mealDietary supplement
GDS, meal
control, no mealDietary supplement
control, no meal
control, mealDietary supplement
control, meal
| Study group | Role | What they receive |
|---|---|---|
| GDS, meal | Experimental | GDS, meal Receives: Dietary Supplement: GDS, meal |
| GDS, no meal | Experimental | GDS, no meal Receives: Dietary Supplement: GDS, no meal |
| control, no meal | Active comparator | control, no meal Receives: Dietary Supplement: control, no meal |
| control, meal | Active comparator | control, meal Receives: Dietary Supplement: control, meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
fractional iron absorption
Measured: 2, 4, 6, and 8 weeks
Secondary outcomes (1)
serum isotope appearance
Measured: day 1, 15, 29 and 33
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionJun 2013
- Study completionAug 2013
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 4 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874496
- Sponsor's protocol ID
- EK 2013-N-05
- Status last verified
- Sep 2013
- First submitted
- 13 May 2013
- Last updated
- 13 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2013. 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
- ClinicalTrials.gov ID
- NCT01874496
- Acronym / sponsor ID
- EK 2013-N-05
- Conditions
- Iron Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 11 Jun 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 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
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GDS, meal | Experimental | Dietary Supplement: GDS, mealGDS, meal |
| GDS, no meal | Experimental | Dietary Supplement: GDS, no mealGDS, no meal |
| control, no meal | Active comparator | Dietary Supplement: control, no mealcontrol, no meal |
| control, meal | Active comparator | Dietary Supplement: control, mealcontrol, 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 < 35µg/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, no mealGDS, no meal | Dietary supplement | GDS, no meal |
| GDS, mealGDS, meal | Dietary supplement | GDS, meal |
| control, no mealcontrol, no meal | Dietary supplement | control, no meal |
| control, mealcontrol, meal | Dietary supplement | control, meal |
Primary outcome
fractional iron absorption
Time frame: 2, 4, 6, and 8 weeks
1 secondary outcome
serum isotope appearance
Time frame: day 1, 15, 29 and 33
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 13 Sep 2013.
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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.
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, no meal and GDS, 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 13 Sep 2013. 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, 4, 6, and 8 weeks). 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 13 Sep 2013.