Clinical Trial: Brain and Behavior Depending on Timing of Iron Deficiency in Human Infants
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Brain and Behavior Depending on Timing of Iron Deficiency in Human Infants
Brief Summary: It is common in many populations that babies develop iron deficiency or iron deficiency anemia (that is, too few healthy red blood cells due to lack of iron). This is due to rapid growth in infancy combined with limited sources of iron in the infant diet. The amount of iron the baby receives across the placenta during pregnancy is another important factor. This study focuses on infants who are born with less than the usual amount of iron in their bodies. The purposes of the study are to assess effects of lower iron at birth on infant behavior and development and to determine if providing iron supplements to such infants beginning at 6 weeks fosters healthier development. Another part of the study will determine the effects of iron deficiency anemia at different times during infant development.
Detailed Summary:
The project focuses on brain-behavior effects depending on the timing of iron deficiency (ID) and iron repletion in human infants. Iron deficiency (ID) is the world's most common single nutrient disorder, differentially affecting pregnant women and infants everywhere. The study promises to be the first systematic investigation of brain and behavior effects of prenatal dietary iron deficiency in human infants. The design will support comparisons of brain/behavior effects depending on the timing and duration of ID. The study will assess reversibility of effects, depending on timing of ID and its treatment, and examine maternal vs. fetal iron regulatory mechanisms in placenta and white blood cells. State-of-the-art neurophysiologic and behavioral measures will test specific hypotheses regarding effects of ID on sensory, motor, cognitive, affective-social and regulatory functions related to impaired myelination of sensory/motor systems and altered structure, neurotransmitter function and neurometabolism in targeted brain regions (basal ganglia and hippocampus). The study will be conducted in China, a rapidly developing country where ID often occurs among pregnant women and infants in the absence of generalized undernutrition. Cord blood hemoglobin (Hb) and ferritin concentrations will be measured in 1300 rural full-term infants, with iron status determined again at 9 and 18 mo. Brain-behavior assessments in the perinatal period will involve 359 infants ("newborn cohort"): 59 with low Hb ("low birth iron" group) will receive iron; 200 with marginal Hb or low cord ferritin ("marginal birth iron" group) will be randomly assigned at 6 wk, 50 to iron therapy and 150 to vitamins only; and 100 with normal cord Hb and ferritin levels ("normal birth iron" group) will receive vitamins only. The remaining 763 infants with cord blood testing will form the "blood screen cohort." At 9 and
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Current Primary Outcome: Infant behavior and development [ Time Frame: 6 weeks; 9 and 18 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Low or marginal birth iron [ Time Frame: 6 weeks ]
- Infant anemia [ Time Frame: 9 and 18 months ]
Original Secondary Outcome: Same as current
Information By: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Dates:
Date Received: March 21, 2008
Date Started: April 2008
Date Completion:
Last Updated: October 28, 2014
Last Verified: March 2014
