Healthy Infant Development Project
Condition: Iron Deficiency Anemia; Iron Deficiency
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      The Healthy Infant Development Project will determine if providing micronutrient supplements
      to mothers during pregnancy and infants in the first 9 months fosters healthy behavior and
      development in babies.
    

Detailed description: 
      Iron deficiency (ID) is the most common single nutrient disorder in the world, and pregnant
      women and infants are at highest risk. With long-lasting differences in prior studies,
      effects on the developing brain and infant behavior and development are among the most
      worrisome concerns. The proposed study will determine developmental/ behavioral effects of
      preventing ID depending on timing (Aim 1) and duration (Aim 2) of iron supplementation (i.e.,
      pre- and/or early postnatally). The study will relate outcomes to severity of ID (Aim 3) and
      consider reversibility of effects with iron therapy, depending on timing (Aim 4). We expect
      different neurobehavioral effects when ID occurs or is prevented/treated during different
      phases of brain development (proliferation and growth phase primarily prenatally and regional
      diversification and interconnection largely in infancy). The project entails 2 randomized
      controlled trials (RCTs) to support causal inferences about preventing ID pre- and/or early
      postnatally. The project builds on a large US CDC-supported study (Pregnancy Nutrition Study)
      involving pregnant women in rural China (ClinicalTrials.gov identifier: NCT00133744). Study
      groups of infants in the proposed RCTs combined are a) pre- and early postnatal iron, b)
      prenatal iron, c) early postnatal iron, and d) neither (n = 500/group, total 2000, at study
      end). Iron status and sensitive sensory, motor, cognitive, language, and social-emotional
      outcomes will be assessed at birth, 9 and 18 mo. Results of Aims 1 & 2 will determine the
      best window to prevent ID effects and whether breast-fed infants benefit from iron before 6
      mo. Aim 3 (severity) will determine the level of ID at which different developmental domains
      are adversely affected. If ill effects of ID without anemia are documented, there could be
      major policy implications; screening is currently only for anemia. Detecting more or less
      vulnerable domains may also point to other interventions in addition to iron therapy. To
      identify reversibile effects, depending on age of treatment (Aim 4), outcomes at 18 mo will
      be compared for infants 1) never iron-deficient, 2) poor iron status at birth and assigned to
      postnatal iron, 3) maternal IDA (anemia) treated in the 1st or 2nd trimester, 4) infant IDA
      treated at 9 mo, and 5) IDA treated at 18 mo. The results will be highly relevant to global
      practice and policy regarding ID, which differentially affects poor and/or minority women and
      infants everywhere.

      The project is expected to continue with a 5-year follow-up (Nov 2014- Oct 2019).
    

Intervention name(s): folic acid + iron prenatally, vits A & D + iron postnatally; folic acid + iron prenatally, vitamins A & D postnatally; folic acid prenatally, vitamins A & D + iron postnatally; folic acid prenatally, vitamins A & D postnatally
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Prenatally: pills by mouth, one per day, from the first prenatal visit until delivery, 400 mcg folic acid, 30 mg Fe.
Postnatally: liquid by mouth, once per day, from 6 weeks old until 9 months old, 1 mg/kg/day Fe, 1500 IU vitamin A, 500 IU vitamin D.; Prenatally: pills by mouth, one per day, from the first prenatal visit until delivery, 400 mcg folic acid, 30 mg Fe.
Postnatally: liquid by mouth, once per day, from 6 weeks old until 9 months old, 1500 IU vitamin A, 500 IU vitamin D.; Prenatally: pills by mouth, one per day, from the first prenatal visit until delivery, 400 mcg folic acid.
Postnatally: liquid by mouth, once per day, from 6 weeks old until 9 months old, 1 mg/kg/day Fe, 1500 IU vitamin A, 500 IU vitamin D.; Prenatally: pills by mouth, one per day, from the first prenatal visit until delivery, 400 mcg folic acid.
Postnatally: liquid by mouth, once per day, from 6 weeks old until 9 months old, 1500 IU vitamin A, 500 IU vitamin D.
Intervention MeSH terms: Vitamin D; Vitamins; Folic Acid; Vitamin A; Iron; Vitamin B Complex; Retinol palmitate
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: iron deficiency anemia; iron deficiency; infant; development; behavior