Prevention of AnemiaPhase 1/2NCT02957643
Substitution of the Normal Levels of Iron and Hemoglobin in Pregnant Women With Iron Supplement
A Phase 1/2 study testing Iron in people with Prevention of Anemia, run by Hippocration General Hospital.
Trial summary
The purpose of the study is to investigate the effectiveness of iron in the treatment of iron deficiency in pregnant 2nd and 3rd quarter. Every 30 days the investigators measure the hemoglobin, hematocrit and iron in serum and assess the course of treatment. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Prevention of Anemia
- What is being tested?
- Iron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to 1 Sep 2017
- Phase
- Phase 1/2
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age more or equal of 18 years
- Registration consent
- Have complete 12h week of pregnancy
- Hemoglobin levels <10,5 ptl
- Hematocrit < 32 %
Who cannot join
- Age <18 years
- Absent registration consent
- Step of pregnancy less than 12 weeks
- Coadministration formulations iron oral or parenterally
- Background of liver kirrosis
- Background of aimosidirosis
Show all 11Show fewer
- Background acquired or chronic aimatochromatosis
- Aplastic , Hemolytic anemia and chronic diseases
- Chronic pancreatitis
- Subjective renal or/and liver disease
- Hypothyroidism or yperthyreoeidismos
About this study
Official title: Treatment of Iron Defieciency Anemia
The purpose of the study is to investigate the effectiveness of iron in the treatment of iron deficiency in pregnant 2nd and 3rd quarter. Every 30 days the investigators measure the hemoglobin, hematocrit and iron in serum and assess the course of treatment.
Read the detailed description
The purpose of the study is to investigate the effectiveness of iron in the treatment of iron deficiency in pregnant 2nd and 3rd quarter. Every 30 days the investigators measure the hemoglobin, hematocrit and iron in serum and assess the course of treatment
- Conditions
- Prevention of Anemia
- Being tested
- Iron
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IronDrug
Also called oral iron
oral treatment
| Study group | Role | What they receive |
|---|---|---|
| pregnant women | Placebo comparator | iron dosage 1 per day for 3 months Receives: Drug: Iron |
| pregnant women with anemia | Experimental | iron dosage 1 per day for 6 months Receives: Drug: Iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measured and reported effectiveness of iron in the treatment of iron deficiency in pregnant 2nd and 3rd quarter with questionnaire
Measured and reported effectiveness of iron in the treatment of iron deficiency in pregnant
Measured: up to 24 months
Secondary outcomes (1)
adverse reactions
adverse reactions
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionSep 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of AnemiaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hippocration General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ANGELOS DANIILIDIS, Hippocration General Hospital
- Investigators
- PANAGIOTIS MATSOUKATIDIS, MD,Msc, Principal investigator, Aristotle University Of ThessalonikiCHARALABOS KOLVATZIS, MD, Principal investigator, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957643
- Sponsor's protocol ID
- HippokratioGH
- Status last verified
- Jul 2020
- First submitted
- 12 Oct 2016
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: email contact
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Iron Defieciency Anemia
- ClinicalTrials.gov ID
- NCT02957643
- Acronym / sponsor ID
- HippokratioGH
- Conditions
- Prevention of Anemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hippocration General HospitalUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 8 Nov 2016 (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.
The purpose of the study is to investigate the effectiveness of iron in the treatment of iron deficiency in pregnant 2nd and 3rd quarter. Every 30 days the investigators measure the hemoglobin, hematocrit and iron in serum and assess the course of treatment.
Detailed description
The purpose of the study is to investigate the effectiveness of iron in the treatment of iron deficiency in pregnant 2nd and 3rd quarter. Every 30 days the investigators measure the hemoglobin, hematocrit and iron in serum and assess the course of treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pregnant women | Placebo comparator | Drug: Ironiron dosage 1 per day for 3 months |
| pregnant women with anemia | Experimental | Drug: Ironiron dosage 1 per day for 6 months |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age more or equal of 18 years
- Registration consent
- Have complete 12h week of pregnancy
- Hemoglobin levels <10,5 ptl
- Hematocrit < 32 %
Key exclusion criteria (11 listed)
- Age <18 years
- Absent registration consent
- Step of pregnancy less than 12 weeks
- Coadministration formulations iron oral or parenterally
- Background of liver kirrosis
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 |
|---|---|---|
| IronAlso: oral ironoral treatment | Drug | pregnant women, pregnant women with anemia |
Primary outcome
Measured and reported effectiveness of iron in the treatment of iron deficiency in pregnant 2nd and 3rd quarter with questionnaire
Time frame: up to 24 months
Measured and reported effectiveness of iron in the treatment of iron deficiency in pregnant
1 secondary outcome
adverse reactions
Time frame: up to 24 months
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 29 Jul 2020.
- Individual participant dataSharing planned: Yes. email contact
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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.
PANAGIOTIS MATSOUKATIDIS, MD,Msc principal investigator
Aristotle University Of Thessaloniki
CHARALABOS KOLVATZIS, MD principal investigator
Aristotle University Of Thessaloniki
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Iron in people with Prevention of Anemia, run by Hippocration General Hospital.
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 5 inclusion and 11 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 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Measured and reported effectiveness of iron in the treatment of iron deficiency in pregnant 2nd and 3rd quarter with questionnaire (time frame: up to 24 months). 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 29 Jul 2020.