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.
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