Status:
RECRUITING
Choline and Iron Deficiency
Lead Sponsor:
University of Minnesota
Conditions:
Pediatric Iron Deficiency
Anemia
Eligibility:
All Genders
5-7 years
Phase:
PHASE2
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- Developmental disorder
- Severe malnutrition (severe wasting or bipedal edema)
- Known sickle cell disease
- Neurologic disorder, brain injury, or other condition affecting brain development
- Not currently breastfeeding
- Birthweight \< 2000 g
Key Trial Info
Start Date :
August 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 21 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06527391
Start Date
August 11 2025
End Date
September 21 2027
Last Update
August 27 2025
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 555455