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Trial record 70 of 561 for:    maltodextrin

Supplementing Iron and Development in Breastfed Infants (SIDBI Study) (SIDBI)

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ClinicalTrials.gov Identifier: NCT02242188
Recruitment Status : Unknown
Verified February 2017 by Anna Chmielewska, Medical University of Warsaw.
Recruitment status was:  Recruiting
First Posted : September 16, 2014
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Anna Chmielewska, Medical University of Warsaw

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.


Condition or disease Intervention/treatment Phase
Iron Deficiency Drug: Iron Dietary Supplement: Placebo Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Iron Supplementation on Psychomotor Development of Non-anemic Exclusively or Predominantly Breastfed Infants: Randomized, Double-blind, Placebo-controlled Trial.
Study Start Date : September 2015
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding Iron

Arm Intervention/treatment
Experimental: 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.

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.


Placebo Comparator: Placebo

Maltodextrin 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.

Dietary Supplement: Placebo
Maltodextrin (packed in identical sachets as active products)
Other Name: Maltodextrin




Primary Outcome Measures :
  1. Psychomotor development [ Time Frame: 12, 24 and 36 months of age ]
    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.


Secondary Outcome Measures :
  1. Hematological and iron status [ Time Frame: 4, 12 and 24 months ]
    Samples will be analyzed for hemoglobin (Hb) concentration, mean corpuscular volume (MCV), hematocrit (HCT), reticulocytes (RET) concentration, serum ferritin, hepcidin, soluble transferrin receptor and calculated soluble transfferin receptor ratio (sTfR), reticulocyte hemoglobin.

  2. Growth [ Time Frame: 4, 6, 9, 12, 24 and 36 months ]
    Weight, length and head circumference will be recorded at 4, 6, 9, 12, 24 and 36 months.

  3. Behaviour [ Time Frame: 36 months ]
    Behaviour will be assessed with use of child behavioral checklist (CBCL)

  4. Adverse events [ Time Frame: untill 9 months of age (during intervention) ]
    Parents will be asked to fill out a form of possible adverse events of the intervention daily. The symptoms listed in the form will include diarrhoea, vomiting, constipation, discolouration of the stool, fever, and respiratory tract infections. The forms will be collected at each check-up visit during the intervention.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Weeks to 18 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Term singleton infants (>37 weeks gestational age)
  • Birth weight > 2500g
  • Healthy at inclusion
  • Breastfed exclusively or predominantly (>50% meals) at inclusion
  • No previous iron supplementation
  • No previous blood transfusion
  • Informed consent given

Exclusion Criteria:

  • preterm delivery (<37 weeks of gestation)
  • birth weight < 2500 g
  • multiple pregnancy
  • major illness or congenital anomaly
  • being <50% breastfed at the time of inclusion
  • food allergy
  • anaemia (Hb <105 g/L [10.5 g/dL]) at inclusion, lack of informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02242188


Contacts
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Contact: Anna M Chmielewska, MD, PhD 0048602677037 anna.chmielewska@umu.se

Locations
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Poland
Department of Pediatrics, The Medical University of Warsaw Recruiting
Warsaw, Poland, 02091
Contact: Anna M Chmielewska, MD, PhD    +48602677037    anna.chmielewska@umu.se   
Contact: Radosław Dryl, MD    +48791547086    radoslawdryl@onet.eu   
Principal Investigator: Anna M Chmielewska, MD, PhD         
Sub-Investigator: Hania Szajewska, MD, PhD         
Sub-Investigator: Radosław Dryl, MD         
Sub-Investigator: Małgorzata Pieścik-Lech, MD, PhD         
Sub-Investigator: Grzegorz Chmielewski, MD         
Sponsors and Collaborators
Medical University of Warsaw
Investigators
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Principal Investigator: Anna M Chmielewska, MD, PhD The Medical University of Warsaw

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anna Chmielewska, MD, PhD, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT02242188     History of Changes
Other Study ID Numbers: SIDBI study
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: This has not been discussed in the study team.
Keywords provided by Anna Chmielewska, Medical University of Warsaw:
Breastfeeding
Iron supplementation
Psychomotor development
Safety
infants
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs