# Improving Brain Myelination with Iron (Fe) Supplementation in Term Infants with Perinatal Latent Iron Deficiency: A Double-Blind, Randomized, Placebo-Controlled Trial

> **NIH NIH R01** · UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR · 2021 · $1

## Abstract

This project is designed to further develop and strengthen collaborative research on perinatal and neonatal
factors associated with neurological impairments in children. The project will be conducted at Sir Ganga Ram
Hospital, Delhi, India, working in conjunction with the University of Rochester Medical Center, Rochester, NY.
This collaboration was initiated in 2010 with support from an NIH-ICMR funded R03 grant to study jaundice-
associated auditory toxicity in infants. The collaboration was strengthened further by our pilot study in term
infants, which demonstrated that perinatal latent iron deficiency (P-LID) is associated with abnormal auditory
neural myelination (ANM). We now propose a more extensive R01 grant proposal leveraging our joint resources
and prior successful collaborations to further develop the capabilities of our Indian collaborators. We will conduct
a double-blind randomized clinical trial (DBRCT) and evaluate the efficacy and safety of iron supplementation to
improve ANM in term infants with P-LID. Abnormal ANM during the neonatal period has been associated with
negative neurodevelopmental outcomes during early childhood. Worldwide, iron deficiency (ID) is the most
common preventable nutritional disorder that contributes to abnormal neurological outcome across the life span.
Iron is essential for brain myelination which peaks during the perinatal period (2 months before and after birth at
term gestation). Currently, the American Academy of Pediatrics recommends that term infants not receive any
iron supplementation during the first 4 months of life. However, P-LID (serum ferritin < 76 ng/mL) is common at
birth among term infants born to mothers with hypertension, diabetes, or ID anemia during pregnancy. In India,
maternal ID during pregnancy and P-LID among term infants are extremely common. P-LID during the critical
period of peak brain myelination in neonates has been associated with acute and long-lasting abnormal brain
development. These neurodevelopmental disabilities result not only in poor life expectations, but billions of
dollars in annual costs globally to provide affected children with care and special education. Therefore, early
identification of P-LID and optimal iron supplementation during the critical postnatal period of brain maturation
may help to improve brain myelination and prevent neurodevelopmental disabilities. The primary objective of this
DBRCT is to determine if oral iron supplementation of 2 or 4 mg/kg/day for 2 months, compared to placebo, will
be safe and improve ANM, as evaluated by auditory brainstem evoked response, in 255 term infants with P-LID
(165 in India & 90 in the US). In carrying out this DBRCT, we will develop a Center of Excellence in Clinical
Research in New Delhi, India, through education, mentoring and high quality research experiences. In the long-
term, we aim to determine if improving myelination with iron supplementation will enhance long-term
neurodevelopmental outcomes in te...

## Key facts

- **NIH application ID:** 10247643
- **Project number:** 5R01NS108364-03
- **Recipient organization:** UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR
- **Principal Investigator:** SANJIV B AMIN
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1
- **Award type:** 5
- **Project period:** 2019-09-30 → 2021-09-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10247643

## Citation

> US National Institutes of Health, RePORTER application 10247643, Improving Brain Myelination with Iron (Fe) Supplementation in Term Infants with Perinatal Latent Iron Deficiency: A Double-Blind, Randomized, Placebo-Controlled Trial (5R01NS108364-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10247643. Licensed CC0.

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