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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02242188 |
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Date of registration:
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14/09/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Supplementing Iron and Development in Breastfed Infants (SIDBI Study)
SIDBI |
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Scientific title:
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Effect of Iron Supplementation on Psychomotor Development of Non-anemic Exclusively or Predominantly Breastfed Infants: Randomized, Double-blind, Placebo-controlled Trial. |
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Date of first enrolment:
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September 2015 |
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Target sample size:
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220 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02242188 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Poland
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Contacts
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Name:
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Anna M Chmielewska, MD, PhD |
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Address:
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Telephone:
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+48602677037 |
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Email:
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anna.chmielewska@umu.se |
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Affiliation:
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Name:
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Anna M Chmielewska, MD, PhD |
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Address:
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Telephone:
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0048602677037 |
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Email:
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anna.chmielewska@umu.se |
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Affiliation:
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Name:
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Anna M Chmielewska, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Medical University of Warsaw |
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Key inclusion & exclusion criteria
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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
Age minimum:
16 Weeks
Age maximum:
18 Weeks
Gender:
All
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Health Condition(s) or Problem(s) studied
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Iron Deficiency
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Intervention(s)
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Drug: Iron
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Dietary Supplement: Placebo
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Primary Outcome(s)
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Psychomotor development
[Time Frame: 12, 24 and 36 months of age]
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Secondary Outcome(s)
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Adverse events
[Time Frame: untill 9 months of age (during intervention)]
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Growth
[Time Frame: 4, 6, 9, 12, 24 and 36 months]
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Behaviour
[Time Frame: 36 months]
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Hematological and iron status
[Time Frame: 4, 12 and 24 months]
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Secondary ID(s)
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SIDBI study
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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