Choline for infants with iron deficiency anemia
Supplemental Choline to Prevent and Treat Learning and Memory Deficits of Early Iron Deficiency: the SupCHO Study
This trial will see if giving choline together with iron to 6-month-old infants with iron deficiency anemia improves their brain development.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 5 Months to 7 Months |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06527391 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are breastfed infants around 6 months old with iron deficiency anemia (Hb <11.0 g/dL and elevated ZPP), malaria-negative, born ≥2000 g, and without severe malnutrition or neurologic conditions.
Not a fit: Infants with severe wasting or edema, known sickle cell disease, neurologic disorders, non-breastfed infants, very low birthweight (<2000 g), or other exclusionary conditions are unlikely to benefit from or be eligible for this intervention.
Why it matters
Potential benefit: If successful, adding choline to iron treatment could reduce early-life brain injury from iron deficiency and improve memory and learning in affected infants.
How similar studies have performed: Preclinical studies show choline reduces hippocampal damage from early iron deficiency and clinical trials have improved memory in children with fetal alcohol spectrum disorders, but choline has not previously been tested in infants with iron deficiency anemia.
Eligibility criteria
Show full inclusion / exclusion 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 disease * Neurologic disorder, brain injury, or other condition affecting brain development * Not currently breastfeeding * Birthweight \< 2000 g
Where this trial is running
Minneapolis, Minnesota
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.