Choline and Iron Deficiency
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: choline bitartrate, placebo drug.
- Who it may be relevant to
- Registry conditions: Pediatric Iron Deficiency, Anemia. Basic parameters: 5 months — 7 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Supplemental Choline to Prevent and Treat Learning and Memory Deficits of Early Iron Deficiency: the SupCHO Study
Overview
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 dysfunction, underscoring the need for low-cost, easily implementable adjunct therapies to iron to treat or prevent this dysfunction in high-risk populations. GAP Supplementation with the nutrient choline lessens damage to the hippocampus from early-life iron deficiency in pre-clinical models and improves hippocampus-mediated memory in children with Fetal Alcohol Spectrum Disorders. Choline has not been tested in children with iron deficiency anemia, despite strong pre-clinical and clinical evidence supporting a benefit to brain development. HYPOTHESIS: Infants with iron deficiency anemia who receive iron and nine months of daily choline supplements will have better scores on specific neurobehavioral tests of recognition memory than infants who receive iron and placebo. METHODS: This randomized, double-blinded, placebo-controlled clinical trial will randomize 300 6-month-old infants with iron deficiency anemia at Mulago Hospital, Kampala, Uganda, to iron plus choline or iron plus placebo to test the effect of choline on hippocampus-specific and global neurobehavioral outcomes after nine months. RESULTS: Pending IMPACT: If our hypothesis is correct, choline could be added immediately to standard-of-care treatment for iron deficiency anemia. This intervention could safely mitigate the brain dysfunction of early-life iron deficiency that is often undiagnosed until the hippocampal critical window is closing. This simple, low-cost nutrient could thus have life-long benefit for both individuals and the economic and social prosperity of entire regions.
Interventions
- Drug choline bitartrate
Daily supplementation for 9 months with 200 mg choline bitartrate - Other placebo drug
Daily supplementation for 9 months with identical placebo
Primary outcome measures
- Elicited Imitation score [Time frame: 9 months (1 month = 28 days) after enrollment]
- 1) Composite Score on the Mullen Scales of Early Learning; 2) Behavior Rating Scale (BRS) composite score; 3) Early Childhood Vigilance Test (ECVT, computerized test for attention). [Time frame: 9 months (1 month = 28 days) after enrollment]
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 disease
- Neurologic disorder, brain injury, or other condition affecting brain development
- Not currently breastfeeding
- Birthweight < 2000 g
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of Minnesota — Minneapolis
Publications
- Cusick SE, Mupere E, Bangirana P, Baluku RI, Kroupina M, Cheatham CL, Wozniak JR, Georgieff MK. Supplemental choline to prevent and treat learning and memory deficits of early-life iron deficiency (The SupCHO Study): study protocol for a randomized, placebo-controlled trial in Ugandan infants with iron deficiency anemia. Trials. 2025 Nov 19;26(1):524. doi: 10.1186/s13063-025-09246-2. PMID 41257751
Identifiers
NCT: NCT06527391 · 33410