Choline and Iron Deficiency

Recruiting Phase 2 Phase 3 Interventional Study
Pediatric Iron Deficiency Anemia
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
5 Months – 7 Months
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Prevention
Participants needed
300 (estimated)
Sponsor
University of Minnesota · Other
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About This Trial
BACKGROUND: Iron deficiency limits the neurodevelopmental potential of more than 200 million children each year. Iron therapy is typically started when iron deficiency anemia is first diagnosed after screening for anemia or detection of clinical symptoms of iron deficiency anemia at 12 months of age. But iron started at this time does not fully correct earlier iron-deficiency-mediated brain dysfu…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Age 6 months +/- 28 days * Hb \< 11.0 g/dL * ZPP \> = 80 * T\<37.5°C * Malaria-negative based on Rapid Diagnostic Test (RDT) * Mother is HIV-negative. Exclusion Criteria: * Developmental disorder * Severe malnutrition (severe wasting or bipedal edema) * Known sickle cell dis…
Contacts

Sarah Cusick

612-723-1694

scusick@umn.edu

CONTACT