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Brain and Behavior Depending on Timing of Iron Deficiency in Human Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00642863
First Posted: March 25, 2008
Last Update Posted: October 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
March 21, 2008
March 25, 2008
October 29, 2014
April 2008
June 2014   (Final data collection date for primary outcome measure)
Infant behavior and development [ Time Frame: 6 weeks; 9 and 18 months ]
Same as current
Complete list of historical versions of study NCT00642863 on ClinicalTrials.gov Archive Site
  • Low or marginal birth iron [ Time Frame: 6 weeks ]
  • Infant anemia [ Time Frame: 9 and 18 months ]
Same as current
Not Provided
Not Provided
 
Brain and Behavior Depending on Timing of Iron Deficiency in Human Infants
Brain and Behavior Depending on Timing of Iron Deficiency in Human Infants
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.

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 18 mo, the newborn cohort will be reassessed, along with IDA infants from the blood screen cohort - about 58 at 9 mo ("early postnatal IDA") and 48 at 18 mo ("late postnatal IDA"). Approximately 39 marginal-birth-iron vitamins only-treated infants in the newborn cohort may also have IDA at 9 mo ("combined ID"). IDA infants will be treated with vitamins with iron. Differential effects and/or reversibility depending on timing of ID or treatment could inform health policy and practice worldwide. However, the effects of prenatal iron deficiency have received very little study in human infants due in large part to previous thinking, no longer accepted, that the infant was protected. Up to 75% of pregnant women worldwide are anemic, with about half due to ID. An estimated 20-25% of 6- to 24-mo-old infants have IDA, and more have ID without anemia. Thus, the public health implications of study findings could be profound.

The project is expected to continue with a 5-year follow-up (Aug 2013-July 2017).

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Iron Deficiency
  • Iron Deficiency Anemia
  • Dietary Supplement: Ferrous Sulfate (liquid) + vitamins A and D
    a single daily dose of 1-2 mg/kg of elemental iron (5 mg from 6 wk to 9 mo and 15 mg from 9 to 18 mo.) and 1500 IU vitamin A and 500 IU vitamin D from 6 wk to 18 mo.
  • Dietary Supplement: vitamins A and D
    a single daily dose (liquid) of 1500 IU vitamin A and 500 IU vitamin D from 6 wk to 18 mo.
  • Dietary Supplement: Ferrous sulfate (liquid)
    Infants who become iron deficient/anemic at 9 or 18 mo will take a single daily dose of 3 mg/kg of elemental iron for 3 months.
  • Experimental: Low birth iron
    Infants with low birth iron who receive vitamins A and D + iron
    Intervention: Dietary Supplement: Ferrous Sulfate (liquid) + vitamins A and D
  • Experimental: Marginal birth iron 1
    Infants with marginal birth iron randomized to receive vitamins A and D + iron
    Intervention: Dietary Supplement: Ferrous Sulfate (liquid) + vitamins A and D
  • Active Comparator: Marginal birth iron 2
    Infants with marginal birth iron randomized to receive vitamins A and D without iron
    Intervention: Dietary Supplement: vitamins A and D
  • Active Comparator: Normal birth iron
    Infants with normal birth iron who receive vitamins A and D without iron
    Intervention: Dietary Supplement: vitamins A and D
  • Experimental: Combined ID
    Marginal-birth-iron vitamins only-treated infants who have IDA at 9 mo.
    Intervention: Dietary Supplement: Ferrous sulfate (liquid)
  • Experimental: Early postnatal IDA
    Infants with IDA at 9 months whose cord blood was collected at birth but who were not assessed and assigned to vitamins with or without iron at 6 weeks
    Intervention: Dietary Supplement: Ferrous sulfate (liquid)
  • Experimental: Late postnatal IDA
    Infants with IDA at 18 months whose cord blood was collected at birth but who were not assessed and assigned to vitamins with or without iron at 6 weeks. These infants were also not anemic when screened at 9 months.
    Intervention: Dietary Supplement: Ferrous sulfate (liquid)
Clark KM, Li M, Zhu B, Liang F, Shao J, Zhang Y, Ji C, Zhao Z, Kaciroti N, Lozoff B. Breastfeeding, Mixed, or Formula Feeding at 9 Months of Age and the Prevalence of Iron Deficiency and Iron Deficiency Anemia in Two Cohorts of Infants in China. J Pediatr. 2017 Feb;181:56-61. doi: 10.1016/j.jpeds.2016.10.041. Epub 2016 Nov 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1614
June 2014
June 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • infants born at Maternity and Children's Hospitals of Fuyang city in China
  • healthy term newborns from uncomplicated pregnancies for hematology screening
  • healthy full-term singleton infants with cord Hb and ferritin in the low-marginal or normal range for developmental testing

Exclusion Criteria:

  • perinatal complications
Sexes Eligible for Study: All
up to 5 Days   (Child)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00642863
2P01HD039386-06A1( U.S. NIH Grant/Contract )
2P01HD039386-06A1 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
Principal Investigator: Betsy Lozoff, MD University of Michigan
Study Director: Jie Shao, MD Children's Hospital, Zhejiang University School of Medicine
Study Director: Zhengyan Zhao, MD Children's Hospital, Zhejiang University School of Medicine
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP