Healthy InfantsNCT00971672
Incidence of Iron Deficiency Anemia in Toddlers
An observational study of Healthy Infants, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
The frequency of iron deficiency anemia was extensively studied in infants on the first year of life. There is not enough information about the frequency of iron deficiency during the second and third years of life. Read more about this study
- Who is it for?
- Ages 18 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy Infants
- What is being tested?
- Questionnaire filling and laboratory analysis
- How many people
- 260 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2010to Aug 2014
- Phase
- Observational
- 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 36 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: The purpose of this study is to analyze the frequency of Iron deficiency anemia in a group of 400 toddles from age 18 months to 36 months. Two groups of children will be included, 200 children from Jewish origin and 200 from non Jewish origin, mostly Arabs. Children that were previously diagnosed suffering from iron deficiency, children suffering from chronic diseases or were born premature will not be included in the study.
Who may be able to join
- Healthy children that attend the pediatric community clinics.
Who cannot join
- Children that were previously diagnosed suffering from iron deficiency.
- Children suffering from chronic diseases or were born premature will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Pediatric Hematology Unit - Ha'Emek Medical Center
Afula, Afula, 18101
About this study
The frequency of iron deficiency anemia was extensively studied in infants on the first year of life. There is not enough information about the frequency of iron deficiency during the second and third years of life. In a previous study performed in Israel and published in Pediatrics 2006 the incidence of anemia does not decrease towards age 18 months. Then there is reasonable to study the iron deficiency frequency beyond this age.
Read the detailed description
The purpose of this study is to analyze the frequency of Iron deficiency anemia in a group of 400 toddles from age 18 months to 36 months.
Two groups of children will be included, 200 children from Jewish origin and 200 from non Jewish origin, mostly Arabs.
A questionnaire that included demographic characteristics, nutrition and iron supplementation in the first year, growth status, and laboratory results will be filled for each patient.
The laboratory analysis will include complete blood count and serum ferritin analysis.
Children that were previously diagnosed suffering from iron deficiency, children suffering from chronic diseases or were born premature will not be included in the study.
- Conditions
- Healthy Infants
- Being tested
- Questionnaire filling and laboratory analysis
- Keywords
- Infants, Iron Deficiency, Anemia, Healthy infants that attend the pediatric community clinics
- 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.
Questionnaire filling and laboratory analysisOther
A questionnaire that included demographic characteristics, nutrition and iron supplementation in the first year, growth status, and laboratory results will be filled for each patient.
The laboratory analysis will include complete blood count and serum ferritin analysis.
| Study group | Role | What they receive |
|---|---|---|
| Toddlers from Jewish origin | Toddlers from Jewish origin aged 18 to 36 months Receives: Other: Questionnaire filling and laboratory analysis | |
| Toddlers from non Jewish origin | Toddlers aged 18 to 36 months belonging to non Jewish (Arab) population Receives: Other: Questionnaire filling and laboratory analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of anemia (Hemoglobin below normal for age) and Iron deficiency (Low ferritin value)
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 posted4 Sep 2009 (estimated)
- Study startFeb 2010
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy InfantsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Koren Ariel, HaEmek Medical Center, Israel
- Investigators
- Ariel Koren, MD, Principal investigator, Pediatric Dpt B and Pediatric Hemaology Unit - Ha'Emek Medical Center - Afula - Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00971672
- Sponsor's protocol ID
- 0024/09-EMC
- Status last verified
- Aug 2015
- First submitted
- 3 Sep 2009
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Iron Deficiency Anemia in Toddlers
- ClinicalTrials.gov ID
- NCT00971672
- Acronym / sponsor ID
- 0024/09-EMC
- Conditions
- Healthy Infants
- Keywords
- Infants, Iron Deficiency, Anemia, Healthy infants that attend the pediatric community clinics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 4 Sep 2009 (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 frequency of iron deficiency anemia was extensively studied in infants on the first year of life. There is not enough information about the frequency of iron deficiency during the second and third years of life. In a previous study performed in Israel and published in Pediatrics 2006 the incidence of anemia does not decrease towards age 18 months. Then there is reasonable to study the iron deficiency frequency beyond this age.
Detailed description
The purpose of this study is to analyze the frequency of Iron deficiency anemia in a group of 400 toddles from age 18 months to 36 months.
Two groups of children will be included, 200 children from Jewish origin and 200 from non Jewish origin, mostly Arabs.
A questionnaire that included demographic characteristics, nutrition and iron supplementation in the first year, growth status, and laboratory results will be filled for each patient.
The laboratory analysis will include complete blood count and serum ferritin analysis.
Children that were previously diagnosed suffering from iron deficiency, children suffering from chronic diseases or were born premature will not be included in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toddlers from Jewish origin | – | Other: Questionnaire filling and laboratory analysisToddlers from Jewish origin aged 18 to 36 months |
| Toddlers from non Jewish origin | – | Other: Questionnaire filling and laboratory analysisToddlers aged 18 to 36 months belonging to non Jewish (Arab) population |
Who may qualify
- Ages
- 18 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The purpose of this study is to analyze the frequency of Iron deficiency anemia in a group of 400 toddles from age 18 months to 36 months. Two groups of children will be included, 200 children from Jewish origin and 200 from non Jewish origin, mostly Arabs. Children that were previously diagnosed suffering from iron deficiency, children suffering from chronic diseases or were born premature will not be included in the study.
Key inclusion criteria (1 listed)
- Healthy children that attend the pediatric community clinics.
Key exclusion criteria (2 listed)
- Children that were previously diagnosed suffering from iron deficiency.
- Children suffering from chronic diseases or were born premature will not be included in the study.
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 |
|---|---|---|
| Questionnaire filling and laboratory analysisA questionnaire that included demographic characteristics, nutrition and iron supplementation in the first year, growth status, and laboratory results will be filled for each patient. The laboratory analysis will include complete blood count and serum ferritin analysis. | Other | Toddlers from Jewish origin, Toddlers from non Jewish origin |
Primary outcome
Frequency of anemia (Hemoglobin below normal for age) and Iron deficiency (Low ferritin value)
Time frame: One year
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 1 Sep 2015.
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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.
Ariel Koren, MD principal investigator
Pediatric Dpt B and Pediatric Hemaology Unit - Ha'Emek Medical Center - Afula - Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Infants, run by HaEmek Medical Center, Israel 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 2 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 1 Sep 2015. 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.
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?
Frequency of anemia (Hemoglobin below normal for age) and Iron deficiency (Low ferritin value) (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 1 Sep 2015.