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Supplementing Iron and Development in Breastfed Infants (SIDBI Study)

NCT02242188 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2017-02-23

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Iron

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.

DIETARY_SUPPLEMENT

Placebo

Maltodextrin (packed in identical sachets as active products)

Sponsors & Collaborators

  • Medical University of Warsaw

    lead OTHER

Principal Investigators

  • Anna M Chmielewska, MD, PhD · The Medical University of Warsaw

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Weeks
Max Age
18 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2019-01-31
Completion
2019-06-30

Countries

  • Poland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02242188 on ClinicalTrials.gov