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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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12 December 2020 |
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Main ID: |
NCT03359447 |
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Date of registration:
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13/11/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Iron Deficiency Anemia, Iron Supplementation and Genomic Stability in Infants
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Scientific title:
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Effectiveness of Weekly and Daily Iron Supplementation for the Prevention of Iron-deficiency Anemia in Infants. Impact on Genomic Stability |
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Date of first enrolment:
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August 1, 2017 |
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Target sample size:
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204 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03359447 |
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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: Prevention. Masking: Double (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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Argentina
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Contacts
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Name:
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Enrique Martins, Biochemist |
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Address:
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Telephone:
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540221155444457 |
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Email:
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enriqueflmartins@gmail.com |
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Affiliation:
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Name:
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Ana Varea, Biochemist |
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Address:
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Telephone:
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Email:
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Affiliation:
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Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri |
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Name:
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Enrique Martins, Biochemist |
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Address:
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Telephone:
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540221155444457 |
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Email:
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enriqueflmartins@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 3 months old infants, clinically healthy, born to term (>37 weeks), that weighted at
birth between 2500 and 4000 g, that have normal prenatal records.
Exclusion Criteria:
- anemic or iron deficient infants, or that have a chronic pathology, or that have
undergone an acute pathology in the previous 15 days. Children that are receiving
antibiotics or vitamin supplements.
Age minimum:
3 Months
Age maximum:
3 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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Anemia
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Iron-deficiency
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Intervention(s)
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Drug: Daily Ferrous Sulfate
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Drug: Weekly Ferrous Sulfate
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Primary Outcome(s)
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Anemia
[Time Frame: 7 days]
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Secondary Outcome(s)
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Genomic Instability
[Time Frame: 15 days]
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Adverse effects
[Time Frame: Through study completion, an average of 1 year]
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Iron deficiency
[Time Frame: 7 days]
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Adherence
[Time Frame: Through study completion, an average of 1 year]
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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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