Supplementing Iron and Development in Breastfed Infants (SIDBI Study)
SIDBI
Effect of Iron Supplementation on Psychomotor Development of Non-anemic Exclusively or Predominantly Breastfed Infants: Randomized, Double-blind, Placebo-controlled Trial.
1 other identifier
interventional
220
1 country
1
Brief Summary
INTRODUCTION Exclusively breastfed infants are at risk of iron deficiency. American Academy of Pediatrics (AAP) recommends iron supplementation in exclusively breastfed infants beginning at 4 months of age. Uncertainty exists regarding the effects of iron supplementation during infancy on neurodevelopmental outcomes in the absence of anemia. AIM To establish whether psychomotor and mental development is influenced by early iron supplementation in healthy, non-anemic, exclusively or predominantly breastfed infants. METHODS Healthy term newborns will be recruited shortly after birth. If predominantly breastfed (\>50% daily feedings) and non-anemic at 4 months, they will be randomized to receive either an iron supplement (approx.1mg/kg/day) or placebo until 9 months of age. Participants will be assessed with use of Bayley Scales of Infant and Toddler Development (Bayley III) at 12, 24 and 36 months of age.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2015
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2014
CompletedFirst Posted
Study publicly available on registry
September 16, 2014
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedFebruary 23, 2017
February 1, 2017
3.3 years
September 14, 2014
February 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Psychomotor development
Psychomotor development will be assessed with the Bayley Scales of Infant and Toddler Development (Bayley III or BSID III) at 12 and 24 months of age.
12, 24 and 36 months of age
Secondary Outcomes (4)
Hematological and iron status
4, 12 and 24 months
Growth
4, 6, 9, 12, 24 and 36 months
Behaviour
36 months
Adverse events
untill 9 months of age (during intervention)
Study Arms (2)
Iron
EXPERIMENTALFerric pyrophosphate (powder preparation in sachets: Actiferol, SunActive Fe, Sequoia, Poland) in a single daily dose. Three doses will be used: 7 mg for infants up to 7 kg of body weight, 10 mg for infants from 7 to 10 kg of body weight, and 15 mg for those exceeding the weight of 10 kg. Caregivers will be instructed to administer the daily dose at the same time of a day, after mixing the content of the sachet with a little amount of breastmilk or milk formula. The intervention will last from 4 months to 9 months of age.
Placebo
PLACEBO COMPARATORMaltodextrin prepared in sachets. Caregivers will be instructed to administer the daily dose at the same time of a day, after mixing the content of the sachet with a little amount of breastmilk or milk formula. The intervention will last from 4 months to 9 months of age.
Interventions
Ferric pyrophosphate (powder preparation in sachets: Actiferol, SunActive Fe, Sequoia, Poland) in a single daily dose. Three doses will be used: 7 mg for infants up to 7 kg of body weight, 10 mg for infants from 7 to 10 kg of body weight, and 15 mg for those exceeding the weight of 10 kg. Caregivers will be instructed to administer the daily dose at the same time of a day, after mixing the content of the sachet with a little amount of breastmilk or milk formula. The intervention will last from 4 months to 9 months of age.
Maltodextrin (packed in identical sachets as active products)
Eligibility Criteria
You may qualify if:
- Term singleton infants (\>37 weeks gestational age)
- Birth weight \> 2500g
- No previous iron supplementation
- No previous blood transfusion
- Informed consent given
You may not qualify if:
- preterm delivery (\<37 weeks of gestation)
- birth weight \< 2500 g
- multiple pregnancy
- major illness or congenital anomaly
- food allergy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Pediatrics, The Medical University of Warsaw
Warsaw, 02091, Poland
Related Publications (2)
Svensson L, Chmielewski G, Czyzewska E, Domellof M, Konarska Z, Piescik-Lech M, Spath C, Szajewska H, Chmielewska A. Effect of Low-Dose Iron Supplementation on Early Development in Breastfed Infants: A Randomized Clinical Trial. JAMA Pediatr. 2024 Jul 1;178(7):649-656. doi: 10.1001/jamapediatrics.2024.1095.
PMID: 38739382DERIVEDChmielewska A, Chmielewski G, Domellof M, Lewandowski Z, Szajewska H. Effect of iron supplementation on psychomotor development of non-anaemic, exclusively or predominantly breastfed infants: a randomised, controlled trial. BMJ Open. 2015 Nov 24;5(11):e009441. doi: 10.1136/bmjopen-2015-009441.
PMID: 26603252DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anna M Chmielewska, MD, PhD
The Medical University of Warsaw
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
September 14, 2014
First Posted
September 16, 2014
Study Start
September 1, 2015
Primary Completion
January 1, 2019
Study Completion
June 1, 2019
Last Updated
February 23, 2017
Record last verified: 2017-02