Iron DeficiencyPhase 4NCT00248716
Treatment of Anemia in the 2nd Year of Life. Comparison of the Efficacy of Two Different Iron Preparations.
A Phase 4 study testing Ferrous gluconate and iron polysaccharide complex in people with Iron Deficiency and Anemia, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
Healthy toddlers (age 9-18 month) following a routine blood count will be placed in three groups: 1. Iron deficiency with no anemia 2. anemia 3. no anemia and no iron deficiency Following a nutritional questionnaire, parents of all toddlers will receive instruction regarding appropriate nutrition in the 2nd year of… Read more about this study
- Who is it for?
- Ages 9 to 18 months
- Conditions the study is for
- Iron Deficiency, Anemia
- What is being tested?
- Ferrous gluconate and iron polysaccharide complex
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2007to Apr 2009
- 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 9 to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy toddlers age 9-18 months
Who cannot join
- Toddlers with: chronic diseases, prematurity, inherited hematological disease.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Primary Pediatric Care Unit, Ben-Gurion University of the Negev
Beersheba, 84105
Jacob Urkin, MD, MPH, 972-8-6477480, jacobur@clalit.org.il
About this study
Healthy toddlers (age 9-18 month) following a routine blood count will be placed in three groups:
- Iron deficiency with no anemia
- anemia
- no anemia and no iron deficiency Following a nutritional questionnaire, parents of all toddlers will receive instruction regarding appropriate nutrition in the 2nd year of life. Groups 1 and 2 will randomly receive one of two preparations currently in use for treatment of iron deficiency in Israel (Aktiron 35 - Ferrous gluconate and Ferripel-3 - iron polysaccharide complex). Followup blood count will be taken 3 month after recruitment. The study aims to compare the effectiveness of the Iron preparations regarding compliance and efficacy.
The hypothesis is that a significant difference will be detected between the two preparations.
- Conditions
- Iron Deficiency, Anemia
- Being tested
- Ferrous gluconate and iron polysaccharide complex
- Medical subject headings
- Iron Deficiencies, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous gluconate and iron polysaccharide complexDrug
Children with anemia will receive 5mg per kg per day of one of study medications. Treatment period for 3 months
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2005 (estimated)
- Study startFeb 2007
- Primary completionApr 2009 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Jacob Urkin, MD, MPH, Principal investigator, Ben-Gurion University of the Negev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00248716
- Sponsor's protocol ID
- sor458607ctil
- Status last verified
- Apr 2008
- First submitted
- 3 Nov 2005
- Last updated
- 6 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Anemia in the 2nd Year of Life. Comparison of the Efficacy of Two Different Iron Preparations.
- ClinicalTrials.gov ID
- NCT00248716
- Acronym / sponsor ID
- sor458607ctil
- Conditions
- Iron Deficiency, Anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Apr 2009 (estimated)
- First posted
- 4 Nov 2005 (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.
Healthy toddlers (age 9-18 month) following a routine blood count will be placed in three groups:
- Iron deficiency with no anemia
- anemia
- no anemia and no iron deficiency Following a nutritional questionnaire, parents of all toddlers will receive instruction regarding appropriate nutrition in the 2nd year of life. Groups 1 and 2 will randomly receive one of two preparations currently in use for treatment of iron deficiency in Israel (Aktiron 35 - Ferrous gluconate and Ferripel-3 - iron polysaccharide complex). Followup blood count will be taken 3 month after recruitment. The study aims to compare the effectiveness of the Iron preparations regarding compliance and efficacy.
The hypothesis is that a significant difference will be detected between the two preparations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 9 to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy toddlers age 9-18 months
Key exclusion criteria (1 listed)
- Toddlers with: chronic diseases, prematurity, inherited hematological disease.
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 gluconate and iron polysaccharide complexChildren with anemia will receive 5mg per kg per day of one of study medications. Treatment period for 3 months | Drug | – |
Primary outcome
Hemoglobin
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2008.
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Iron Absorption From a Nutritional Iron Supplement
Iron Absorption, Iron Deficiencies
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The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
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The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingPhase 4
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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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.
Jacob Urkin, MD, MPH principal investigator
Ben-Gurion University of the Negev
1 site 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 gluconate and iron polysaccharide complex in people with Iron Deficiency and Anemia, run by Soroka University Medical Center at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 6 May 2008. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacob Urkin, MD, MPH (972-8-6477480, jacobur@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin (time frame: 3 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 6 May 2008.