Choline and Iron Deficiency

NCT06527391 | Recruiting Phase 2 DMC

• 1 other identifier: 33410
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Iron Deficiency; Anemia

Keywords

iron deficiency; choline; anemia

Outcome Measures

Primary Outcomes (2)

• Elicited Imitation score

  Elicited Imitation outcomes (number of items correctly recalled and number of steps recalled in the correct order for both immediate and delayed recall) at age 15 months, i.e., after nine months of daily supplementation with choline or placebo.

  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).

  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).

  9 months (1 month = 28 days) after enrollment

Study Arms (2)

study group

EXPERIMENTAL

participants assigned to receive study drug

Drug: choline bitartrate

control group

PLACEBO COMPARATOR

participants assigned to receive placebo drug

Other: placebo drug

Interventions

choline bitartrate DRUG

Daily supplementation for 9 months with 200 mg choline bitartrate

study group

placebo drug OTHER

Daily supplementation for 9 months with identical placebo

control group

Eligibility Criteria

• Age: 5 Months - 7 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 555455, United States

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Anemia; Iron Deficiencies

Interventions

Choline

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Onium Compounds

Study Officials

• Sarah Cusick

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Cusick

CONTACT

612-723-1694; scusick@umn.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Manufacturer of choline and placebo tablets will randomize the regimens and hold the randomization key
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blinded, placebo-controlled trial of 9 months of daily choline supplementation of 300 6-month-old Ugandan infants with iron deficiency anemia

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 30, 2024
• Study Start: August 11, 2025
• Primary Completion (Estimated): September 21, 2027
• Study Completion (Estimated): September 21, 2027
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

US (1)