Choline for infants with iron deficiency anemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Infants about 6 months old who meet biochemical criteria for iron deficiency anemia are enrolled and randomized to receive oral choline bitartrate or a matching placebo alongside standard iron therapy. Eligibility requires hemoglobin <11.0 g/dL, elevated ZPP, normal temperature, negative malaria test, maternal HIV-negativity, current breastfeeding, and birthweight ≥2000 g, while children with severe malnutrition, neurologic disorders, sickle cell disease, or developmental disorders are excluded. Outcomes focus on hippocampus-related memory and broader neurodevelopmental measures over the treatment and follow-up period. The trial builds on preclinical data and prior clinical work in other pediatric populations to test a low-cost, easily implemented adjunct to iron.

Why it matters

Who can join: the full rules

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 disease
* Neurologic disorder, brain injury, or other condition affecting brain development
* Not currently breastfeeding
* Birthweight \< 2000 g

Where it's running

• University of Minnesota
  Minneapolis, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Sarah Cusick — University of Minnesota
• Study coordinator: Sarah Cusick
• Email: scusick@umn.edu
• Phone: 612-723-1694

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.