Non-anemic Iron DeficiencyOptECNCT01481766
Iron Treatment for Young Children With Non-anemic Iron Deficiency
A study testing Ferrous Sulfate and Dietary counseling in people with Non-anemic Iron Deficiency, run by The Hospital for Sick Children at 2 sites in Canada.
Trial summary
The pre-school years are critical years for children to acquire early learning skills such as language, fine motor and social skills; this is termed early child development. Primary care doctors (family doctors and pediatricians) are in a unique position to identify children with health or developmental problems. Read more about this study
- Who is it for?
- Ages 12 to 40 monthsHealthy volunteers can take part
- Conditions the study is for
- Non-anemic Iron Deficiency
- What is being tested?
- Ferrous Sulfate and Dietary counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 127 participants
- Where
- 2 sitesCanada
- Study dates
- Jun 2012to Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 40 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age between 12 and 40 months attending any well child visit
- Informed parental consent
Who cannot join
- developmental disorder
- genetic, chromosomal or syndromic condition
- chronic medical condition (with the exception of asthma and allergies)
- chronic anemia, iron deficiency, or recent oral iron supplementation or treatment
- prematurity, with a gestational age of less than 35 weeks
- low birth weight less than 2,500 g;
Show all 11Show fewer
- attending the office for an acute illness, such as a viral illness, or other health concern other than for a well-child assessment
- any contraindications to receiving elemental iron
- the use of any natural health product containing the same medicinal ingredient(s) as the investigational product
- English is not spoken to the child in the home or in a child care setting
- CRP level ≥10 mg/L
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
About this study
Official title: Optimizing Early Child Development in the Primary Care Practice Setting: Pragmatic Randomized Trial of Iron Treatment for Young Children With Non-anemic Iron Deficiency (OptEC)
The pre-school years are critical years for children to acquire early learning skills such as language, fine motor and social skills; this is termed early child development. Primary care doctors (family doctors and pediatricians) are in a unique position to identify children with health or developmental problems. Screening is the process of testing healthy people for the earliest signs of health problems, followed by treatment, with the expectation that screening will improve the health of those screened. The focus of this research is screening young children for the earliest signs of iron deficiency (low blood iron levels) followed by treatment with oral iron.
Previous research has shown that children with later stages of iron deficiency have serious delays in their development. Some research has shown that these delays may persist into young adulthood often with a significant reduction in intelligence. Early stages of iron deficiency may be difficult for parents or doctors to detect, and a blood test is usually needed. However, Canadian guidelines do not recommend screening all children for iron deficiency, because there is not enough good quality research to prove that screening is effective.
In this study, the investigators will ask parents to allow their child between the ages of 1 to 3 years to have a blood test for iron levels. If the blood level is low, the child will be randomly assigned to receive either oral iron liquid for 4 months plus diet counseling, or a placebo liquid plus diet counseling. A psychologist will measure each child's early learning ability before and after the treatment. If this approach to screening children's blood iron levels followed by treatment improves children's development, parents and doctors may consider that routine blood screening tests are justified. Overall, this research is an important step to improving the ways in which primary care doctors can ensure that children have the best start to life-long health and achievement.
- Conditions
- Non-anemic Iron Deficiency
- Being tested
- Ferrous Sulfate, Placebo, Dietary counseling
- Keywords
- child development, screening, Non-anemic iron deficiency, primary care pediatrics, prevention and health promotion
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous SulfateDietary supplement
Also called Brand name: Fer-In-Sol by Mead Johnson Nutrition, NPN #: 00762954
6 mg elemental iron/kg/day (0.4 ml/kg/day) in 2 or 3 divided doses (at the discretion of prescribing study doctor) for four months plus dietary counseling
PlaceboDietary supplement
0.4 ml/kg/day in 2 or 3 divided doses (at the discretion of prescribing study doctor) for four months plus dietary counseling
Dietary counselingBehavioural
Dietary counseling will include written recommendations regarding maximum daily cow's milk intake, varied solid food intake including high iron containing foods, and avoidance of foods which reduce iron absorption.
| Study group | Role | What they receive |
|---|---|---|
| Iron plus dietary counseling (Non-anemic iron deficiency) | Experimental | Not described Receives: Dietary Supplement: Ferrous Sulfate; Behavioral: Dietary counseling |
| Placebo plus dietary counseling (Non-anemic iron deficiency) | Placebo comparator | Not described Receives: Dietary Supplement: Placebo; Behavioral: Dietary counseling |
| Iron sufficient | No intervention | From the screening cohort of it is anticipated that 25 children will have iron deficiency anemia and an equal number of randomly selected children with iron sufficiency (n=25) will be sampled. These children will be compared to the children with non-anemic iron deficiency. |
| Iron deficiency anemia | Active comparator | From the screening cohort of it is anticipated that 25 children will have iron deficiency anemia and an equal number of randomly selected children with iron sufficiency (n=25) will be sampled. These children will be compared to the children with non-anemic iron deficiency. Receives: Dietary Supplement: Ferrous Sulfate; Behavioral: Dietary counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Learning Composite (ELC) From the Mullen Scales of Early Learning
ELC is a measure of infant cognition (similar to IQ). In populations, infants have a mean score of 100 points and standard deviation of 15 points. A higher score indicates higher cognitive ability. Four cognitive skills are summarized into an Early Learning Composite score - Fine Motor, Visual Reception, Receptive Language, and Expressive Language.
Measured: Baseline and 4 months after enrollment
Secondary outcomes (1)
Serum Ferritin
Blood samples analyzed for serum ferritin
Measured: 4 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startJun 2012
- Primary completionOct 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Non-anemic Iron DeficiencyStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Mead Johnson Nutrition, Mount Sinai Hospital, Canada, Unity Health Toronto
- Responsible party
- Sponsor
- Investigators
- Parkin C Parkin, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481766
- Sponsor's protocol ID
- 1000027782
- Acronym
- OptEC
- Status last verified
- Oct 2025
- First submitted
- 22 Nov 2011
- Last updated
- 30 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Parkin PC, Borkhoff CM, Macarthur C, Abdullah K, Birken CS, Fehlings D, Koroshegyi C, Maguire JL, Mamak E, Mamdani M, Thorpe KE, Zlotkin SH, Zuo F; TARGet Kids! Collaboration. Randomized Trial of Oral Iron and Diet Advice versus Diet Advice Alone in Young Children with Nonanemic Iron Deficiency. J Pediatr. 2021 Jun;233:233-240.e1. doi: 10.1016/j.jpeds.2021.01.073. Epub 2021 Feb 4.
PubMed 33548262Gingoyon A, Borkhoff CM, Koroshegyi C, Mamak E, Birken CS, Maguire JL, Fehlings D, Macarthur C, Parkin PC. Chronic Iron Deficiency and Cognitive Function in Early Childhood. Pediatrics. 2022 Dec 1;150(6):e2021055926. doi: 10.1542/peds.2021-055926.
PubMed 36412051Parkin PC, Koroshegyi C, Mamak E, Borkhoff CM, Birken CS, Maguire JL, Thorpe KE; TARGet Kids! Collaboration. Association between Serum Ferritin and Cognitive Function in Early Childhood. J Pediatr. 2020 Feb;217:189-191.e2. doi: 10.1016/j.jpeds.2019.09.051. Epub 2019 Nov 2.
PubMed 31685227Abdullah K, Thorpe KE, Mamak E, Maguire JL, Birken CS, Fehlings D, Hanley AJ, Macarthur C, Zlotkin SH, Parkin PC. An internal pilot study for a randomized trial aimed at evaluating the effectiveness of iron interventions in children with non-anemic iron deficiency: the OptEC trial. Trials. 2015 Jul 14;16:303. doi: 10.1186/s13063-015-0829-4.
PubMed 26170014Abdullah K, Thorpe KE, Mamak E, Maguire JL, Birken CS, Fehlings D, Hanley AJ, Macarthur C, Zlotkin SH, Parkin PC. Optimizing early child development for young children with non-anemic iron deficiency in the primary care practice setting (OptEC): study protocol for a randomized controlled trial. Trials. 2015 Apr 2;16:132. doi: 10.1186/s13063-015-0635-z.
PubMed 25873050
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Early Child Development in the Primary Care Practice Setting: Pragmatic Randomized Trial of Iron Treatment for Young Children With Non-anemic Iron Deficiency (OptEC)
- ClinicalTrials.gov ID
- NCT01481766
- Acronym / sponsor ID
- OptEC / 1000027782
- Conditions
- Non-anemic Iron Deficiency
- Keywords
- child development, screening, Non-anemic iron deficiency, primary care pediatrics, prevention and health promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Mead Johnson Nutrition, Mount Sinai Hospital, Canada, Unity Health Toronto
- Study start
- Jun 2012 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 30 Nov 2011 (estimated)
- Results
- Posted 30 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The pre-school years are critical years for children to acquire early learning skills such as language, fine motor and social skills; this is termed early child development. Primary care doctors (family doctors and pediatricians) are in a unique position to identify children with health or developmental problems. Screening is the process of testing healthy people for the earliest signs of health problems, followed by treatment, with the expectation that screening will improve the health of those screened. The focus of this research is screening young children for the earliest signs of iron deficiency (low blood iron levels) followed by treatment with oral iron.
Previous research has shown that children with later stages of iron deficiency have serious delays in their development. Some research has shown that these delays may persist into young adulthood often with a significant reduction in intelligence. Early stages of iron deficiency may be difficult for parents or doctors to detect, and a blood test is usually needed. However, Canadian guidelines do not recommend screening all children for iron deficiency, because there is not enough good quality research to prove that screening is effective.
In this study, the investigators will ask parents to allow their child between the ages of 1 to 3 years to have a blood test for iron levels. If the blood level is low, the child will be randomly assigned to receive either oral iron liquid for 4 months plus diet counseling, or a placebo liquid plus diet counseling. A psychologist will measure each child's early learning ability before and after the treatment. If this approach to screening children's blood iron levels followed by treatment improves children's development, parents and doctors may consider that routine blood screening tests are justified. Overall, this research is an important step to improving the ways in which primary care doctors can ensure that children have the best start to life-long health and achievement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Iron plus dietary counseling (Non-anemic iron deficiency) | Experimental | Dietary Supplement: Ferrous Sulfate, Behavioral: Dietary counseling |
| Placebo plus dietary counseling (Non-anemic iron deficiency) | Placebo comparator | Dietary Supplement: Placebo, Behavioral: Dietary counseling |
| Iron sufficient | No intervention | –From the screening cohort of it is anticipated that 25 children will have iron deficiency anemia and an equal number of randomly selected children with iron sufficiency (n=25) will be sampled. These children will be compared to the children with non-anemic iron deficiency. |
| Iron deficiency anemia | Active comparator | Dietary Supplement: Ferrous Sulfate, Behavioral: Dietary counselingFrom the screening cohort of it is anticipated that 25 children will have iron deficiency anemia and an equal number of randomly selected children with iron sufficiency (n=25) will be sampled. These children will be compared to the children with non-anemic iron deficiency. |
Who may qualify
- Ages
- 12 to 40 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age between 12 and 40 months attending any well child visit
- Informed parental consent
Key exclusion criteria (11 listed)
- developmental disorder
- genetic, chromosomal or syndromic condition
- chronic medical condition (with the exception of asthma and allergies)
- chronic anemia, iron deficiency, or recent oral iron supplementation or treatment
- prematurity, with a gestational age of less than 35 weeks
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 SulfateAlso: Brand name: Fer-In-Sol by Mead Johnson Nutrition, NPN #: 007629546 mg elemental iron/kg/day (0.4 ml/kg/day) in 2 or 3 divided doses (at the discretion of prescribing study doctor) for four months plus dietary counseling | Dietary supplement | Iron deficiency anemia, Iron plus dietary counseling (Non-anemic iron deficiency) |
| Placebo0.4 ml/kg/day in 2 or 3 divided doses (at the discretion of prescribing study doctor) for four months plus dietary counseling | Dietary supplement | Placebo plus dietary counseling (Non-anemic iron deficiency) |
| Dietary counselingDietary counseling will include written recommendations regarding maximum daily cow's milk intake, varied solid food intake including high iron containing foods, and avoidance of foods which reduce iron absorption. | Behavioural | Iron deficiency anemia, Iron plus dietary counseling (Non-anemic iron deficiency), Placebo plus dietary counseling (Non-anemic iron deficiency) |
Primary outcome
Early Learning Composite (ELC) From the Mullen Scales of Early Learning
Time frame: Baseline and 4 months after enrollment
ELC is a measure of infant cognition (similar to IQ). In populations, infants have a mean score of 100 points and standard deviation of 15 points. A higher score indicates higher cognitive ability. Four cognitive skills are summarized into an Early Learning Composite score - Fine Motor, Visual Reception, Receptive Language, and Expressive Language.
1 secondary outcome
Serum Ferritin
Time frame: 4 months after enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33548262Parkin PC, Borkhoff CM, Macarthur C, Abdullah K, Birken CS, Fehlings D, Koroshegyi C, Maguire JL, Mamak E, Mamdani M, Thorpe KE, Zlotkin SH, Zuo F; TARGet Kids! Collaboration. Randomized Trial of Oral Iron and Diet Advice versus Diet Advice Alone in Young Children with Nonanemic Iron Deficiency. J Pediatr. 2021 Jun;233:233-240.e1. doi: 10.1016/j.jpeds.2021.01.073. Epub 2021 Feb 4.
- Results publication: PubMed 36412051Gingoyon A, Borkhoff CM, Koroshegyi C, Mamak E, Birken CS, Maguire JL, Fehlings D, Macarthur C, Parkin PC. Chronic Iron Deficiency and Cognitive Function in Early Childhood. Pediatrics. 2022 Dec 1;150(6):e2021055926. doi: 10.1542/peds.2021-055926.
- Derived from this study: PubMed 31685227Parkin PC, Koroshegyi C, Mamak E, Borkhoff CM, Birken CS, Maguire JL, Thorpe KE; TARGet Kids! Collaboration. Association between Serum Ferritin and Cognitive Function in Early Childhood. J Pediatr. 2020 Feb;217:189-191.e2. doi: 10.1016/j.jpeds.2019.09.051. Epub 2019 Nov 2.
- Derived from this study: PubMed 26170014Abdullah K, Thorpe KE, Mamak E, Maguire JL, Birken CS, Fehlings D, Hanley AJ, Macarthur C, Zlotkin SH, Parkin PC. An internal pilot study for a randomized trial aimed at evaluating the effectiveness of iron interventions in children with non-anemic iron deficiency: the OptEC trial. Trials. 2015 Jul 14;16:303. doi: 10.1186/s13063-015-0829-4.
- Derived from this study: PubMed 25873050Abdullah K, Thorpe KE, Mamak E, Maguire JL, Birken CS, Fehlings D, Hanley AJ, Macarthur C, Zlotkin SH, Parkin PC. Optimizing early child development for young children with non-anemic iron deficiency in the primary care practice setting (OptEC): study protocol for a randomized controlled trial. Trials. 2015 Apr 2;16:132. doi: 10.1186/s13063-015-0635-z.
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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.
Parkin C Parkin, MD principal investigator
The Hospital for Sick Children
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ferrous Sulfate and Dietary counseling in people with Non-anemic Iron Deficiency, run by The Hospital for Sick Children at 2 sites in Canada.
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 2 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 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Early Learning Composite (ELC) From the Mullen Scales of Early Learning (time frame: Baseline and 4 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01481766, which also lists 5 linked publications.
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 Oct 2025.