Actively Recruiting

Phase 2
Phase 3
Age: 5Months - 7Months
All Genders
ID06527391

Supplemental Choline to Prevent and Treat Learning and Memory Deficits of Early Iron Deficiency in Infants

Led by University of Minnesota · Updated on 2025-08-27

300

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether daily supplementation with choline, alongside standard iron therapy, can improve memory and learning abilities in infants aged around 6 months who have iron deficiency anemia. This study is a randomized, double-blinded, placebo-controlled clinical trial involving 300 infants and aims to address brain dysfunction caused by early-life iron deficiency that is not fully corrected by iron alone. The trial is led by the University of Minnesota and investigates the potential benefits of adding choline, a low-cost nutrient, to standard treatment to support brain development.

CONDITIONS

Brief Title

Choline and Iron Deficiency

Who Can Participate

Age: 5Months - 7Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 6 months plus or minus 28 days
  • Hemoglobin below 11.0 g/dL
  • Zinc protoporphyrin (ZPP) level at least 80
  • Body temperature below 37.56C
  • Negative malaria test by rapid diagnostic test
  • Mother is HIV-negative
Not Eligible

You will not qualify if you...

  • Developmental disorder
  • Severe malnutrition such as severe wasting or bipedal edema
  • Known sickle cell disease
  • Neurologic disorder, brain injury, or other brain development conditions
  • Not currently breastfeeding
  • Birthweight less than 2000 grams

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 9 months

Participants receive daily supplementation with either 200 mg choline bitartrate or a placebo for 9 months.

Daily supplementation with study drug or placebo

Trial Site Locations

Total: 1 location

1

University of Minnesota

Minneapolis, Minnesota, United States, 555455

Actively Recruiting

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Research Team

S

Sarah Cusick

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

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.

Sarah E Cusick, Ezekiel Mupere, Paul Bangirana...

https://pubmed.ncbi.nlm.nih.gov/41257751