Neurodevelopmental DisordersNCT02690675
Iron Supplement Effect on Child Development
A study testing Iron fortified formula milk in people with Neurodevelopmental Disorders and Lactation, run by University Rovira i Virgili.
Trial summary
Objective: To evaluate the effect of Iron supplement with two different amounts (one in the higher limit and another in the lower limit of the suggested amount) according to the presence of mutations in the HFE gene in the physical, immune and neurobehavioral development in the 6 to 12 moth toddlers. Read more about this study
- Who is it for?
- Ages Up to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Neurodevelopmental Disorders, Lactation
- What is being tested?
- Iron fortified formula milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- No sites listed yet
- Study dates
- May 2006to Dec 2009
- 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 Up to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Caucasian infants
- Healthy term infants
Who cannot join
- Families that do not understand Spanish or Catalan
- Anaemic infants at birth
- Infants with important diseases
About this study
Official title: Iron Supplement Effect Over Immune System and Neurobehavioral Child Development.
Objective: To evaluate the effect of Iron supplement with two different amounts (one in the higher limit and another in the lower limit of the suggested amount) according to the presence of mutations in the HFE gene in the physical, immune and neurobehavioral development in the 6 to 12 moth toddlers.
Methodology: Subjects: 340 toddlers coming from Paediatric Serves of Sant Joan Hospital. Methods: At 6 and 12 months it done clinical history, food registry, biochemist determinations: haemoglobin, iron, transferrin, ferritin, reactive C protein and immune response (IL4, IL10, IL6 IFN, IgA, IgM, IgG, IgE). Mutations in the HFE gene: C282Y, H63D, S65D and hepcidin gene. Mental, psychomotor and behavioual development (Bayley Scales of Infant Development 2on Edition: 1993). We evaluate the level of language and communication (MacArthur), regulation and sensory process (Infant Toddler Symptom Checklist), familiar and environment surroundings (Scale Health General Parental Stress Index).
Read the detailed description
Design: Randomised Clinical Trial with two groups of intervention. Group A received high-iron fortified milk (1.2mg/100mL) and Group B received low-iron fortified milk (0.4mg/100mL).
Inclusion criteria: caucasian new-borns, term infants.
Exclusion criteria:
- Families that refuse enter at the follow-up.
- Low-birth weight or preterm infants.
- Anaemic infants.
- Infants with congenital defects, immunodeficiency or hypothyroidism.
- Infants with diseases that requires intensive care.
- Conditions
- Neurodevelopmental Disorders, Lactation
- Being tested
- Iron fortified formula milk
- Keywords
- Neurodevelopment, Bayley Scale, Growth, Iron fortification
- Medical subject headings
- Neurodevelopmental Disorders, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron fortified formula milkDietary supplement
One group received formula milk fortified with 1.2 mg/100 mL and the other group 0.4 mg/100mL between 6 and 12 months of age.
| Study group | Role | What they receive |
|---|---|---|
| Intervention high-iron fortified milk | Experimental | This group received a high dose of iron by formula milk (1.2mg/100mL) between 6 and 12 months of age. Receives: Dietary Supplement: Iron fortified formula milk |
| Intervention low-iron fortified milk | Experimental | This group received a low dose of iron by formula milk (0.4mg/100mL) between 6 and 12 months of age. Receives: Dietary Supplement: Iron fortified formula milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental and psychomotor development with BSID (Bayley Scale of Infant Development) at 12 months.
Measured: 12 months
Secondary outcomes (4)
Height at 12 months measured in centimeters
Measured: 12 months
Weight at 12 months measured in grams
Measured: 12 months
Head circumference at 12 months measured in centimeters
Measured: 12 months
Risk of infections at 12 months measured qualitatively from record of presence or not of various infections as bronchitis, rhinitis, otitis etc.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startMay 2006
- Primary completionJun 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurodevelopmental DisordersStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Rovira i Virgili
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victoria Arija Val, University Rovira i Virgili
- Investigators
- Victoria Arija Val, Professor, Principal investigator, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02690675
- Sponsor's protocol ID
- EC81/00128
- Status last verified
- Feb 2016
- First submitted
- 11 Feb 2016
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The investigators plan to share data in a submitted article in 2016
Publications
Iglesias Vazquez L, Canals J, Voltas N, Jardi C, Hernandez C, Bedmar C, Escribano J, Aranda N, Jimenez R, Barroso JM, Ribot B, Arija V. Does the fortified milk with high iron dose improve the neurodevelopment of healthy infants? Randomized controlled trial. BMC Pediatr. 2019 Sep 5;19(1):315. doi: 10.1186/s12887-019-1679-0.
PubMed 31488098
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Supplement Effect Over Immune System and Neurobehavioral Child Development.
- ClinicalTrials.gov ID
- NCT02690675
- Acronym / sponsor ID
- EC81/00128
- Conditions
- Neurodevelopmental Disorders, Lactation
- Keywords
- Neurodevelopment, Bayley Scale, Growth, Iron fortification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- University Rovira i VirgiliUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 24 Feb 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.
Objective: To evaluate the effect of Iron supplement with two different amounts (one in the higher limit and another in the lower limit of the suggested amount) according to the presence of mutations in the HFE gene in the physical, immune and neurobehavioral development in the 6 to 12 moth toddlers.
Methodology: Subjects: 340 toddlers coming from Paediatric Serves of Sant Joan Hospital. Methods: At 6 and 12 months it done clinical history, food registry, biochemist determinations: haemoglobin, iron, transferrin, ferritin, reactive C protein and immune response (IL4, IL10, IL6 IFN, IgA, IgM, IgG, IgE). Mutations in the HFE gene: C282Y, H63D, S65D and hepcidin gene. Mental, psychomotor and behavioual development (Bayley Scales of Infant Development 2on Edition: 1993). We evaluate the level of language and communication (MacArthur), regulation and sensory process (Infant Toddler Symptom Checklist), familiar and environment surroundings (Scale Health General Parental Stress Index).
Detailed description
Design: Randomised Clinical Trial with two groups of intervention. Group A received high-iron fortified milk (1.2mg/100mL) and Group B received low-iron fortified milk (0.4mg/100mL).
Inclusion criteria: caucasian new-borns, term infants.
Exclusion criteria:
- Families that refuse enter at the follow-up.
- Low-birth weight or preterm infants.
- Anaemic infants.
- Infants with congenital defects, immunodeficiency or hypothyroidism.
- Infants with diseases that requires intensive care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention high-iron fortified milk | Experimental | Dietary Supplement: Iron fortified formula milkThis group received a high dose of iron by formula milk (1.2mg/100mL) between 6 and 12 months of age. |
| Intervention low-iron fortified milk | Experimental | Dietary Supplement: Iron fortified formula milkThis group received a low dose of iron by formula milk (0.4mg/100mL) between 6 and 12 months of age. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Caucasian infants
- Healthy term infants
Key exclusion criteria (3 listed)
- Families that do not understand Spanish or Catalan
- Anaemic infants at birth
- Infants with important diseases
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 |
|---|---|---|
| Iron fortified formula milkOne group received formula milk fortified with 1.2 mg/100 mL and the other group 0.4 mg/100mL between 6 and 12 months of age. | Dietary supplement | Intervention high-iron fortified milk, Intervention low-iron fortified milk |
Primary outcome
Mental and psychomotor development with BSID (Bayley Scale of Infant Development) at 12 months.
Time frame: 12 months
4 secondary outcomes
Height at 12 months measured in centimeters
Time frame: 12 months
Weight at 12 months measured in grams
Time frame: 12 months
Head circumference at 12 months measured in centimeters
Time frame: 12 months
Risk of infections at 12 months measured qualitatively from record of presence or not of various infections as bronchitis, rhinitis, otitis etc.
Time frame: 12 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 25 Feb 2016.
- Derived from this study: PubMed 31488098Iglesias Vazquez L, Canals J, Voltas N, Jardi C, Hernandez C, Bedmar C, Escribano J, Aranda N, Jimenez R, Barroso JM, Ribot B, Arija V. Does the fortified milk with high iron dose improve the neurodevelopment of healthy infants? Randomized controlled trial. BMC Pediatr. 2019 Sep 5;19(1):315. doi: 10.1186/s12887-019-1679-0.
- Individual participant dataSharing planned: Yes. The investigators plan to share data in a submitted article in 2016
Related trials for Neurodevelopmental Disorders
Active, not recruitingPhase 3
A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)
Dravet Syndrome
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Not yet recruiting
Single Session Support for Parents of Children With Neurodevelopmental Disabilities Struggling With Anxious Avoidance
Neurodevelopmental Disorders, Autism Spectrum Disorder (ASD)
Recruiting
Loving Habits: A Feasibility Study of a Support Program for Building New Parent-child Behavioral Habits
ADHD
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.
Victoria Arija Val, Professor principal investigator
University Rovira i Virgili
Questions about this trial
What is this clinical trial studying?
A study testing Iron fortified formula milk in people with Neurodevelopmental Disorders and Lactation, run by University Rovira i Virgili.
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 3 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 25 Feb 2016. 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. 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?
Mental and psychomotor development with BSID (Bayley Scale of Infant Development) at 12 months. (time frame: 12 months). 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 NCT02690675, which also lists 1 linked publication.
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 25 Feb 2016.