Pediatric Iron Deficiency study: Choline bitartrate
Official title Choline and Iron Deficiency
ClinicalTrials.gov ID: NCT06527391
What this study is testing
What is choline bitartrate?
an investigational dietary supplement being studied as an adjunct to iron therapy for pediatric iron deficiency anemia to improve neurodevelopmental outcomes is designed to support brain development and memory function by providing choline, a nutrient involved in cell membrane formation and neurotransmitter synthesis
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if giving choline together with iron leads to better scores on memory and other neurobehavioral tests compared with iron alone.
- Who it's for
- Infants who are 6 months old and have been diagnosed with iron‑deficiency anemia.
- What's involved
- Children will receive the standard iron treatment plus either a daily choline supplement or a placebo for nine months, with study visits for safety checks and memory testing.
- Time commitment
- The trial lasts about nine months and includes regular clinic visits for supplement distribution and neurobehavioral assessments.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 7
You may be able to join 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)
You likely can't join 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 months to 7 months. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Minneapolis, Minnesota, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.