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โ† Trials
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Choline and Iron Deficiency

RecruitingPhase 2, Phase 3Ages 5 Months - 7 MonthsAllUniversity of Minnesota
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age 6 months +/- 28 days * Hb \< 11.0 g/dL * ZPP \> = 80 * T\<37.5ยฐC * 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
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What it tests

  • choline bitartrate
  • placebo drug
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Where

1 site
University of Minnesota
Minneapolis, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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